Shailesh M. Chaudhary
Medical Professional (Doctor) - Pharmacovigilance Services
Dombivili,MH
Summary
Seeking challenging assignments in PHARMACOVIGILANCE with an organization of repute.
Core Pharmacovigilance Experience – 15 years An effective communicator with innovative thinking, strong relationship management, people management, and managerial skills Planning, coordination, analytical and problem-solving skills.
Versatile Senior Manager specializing in of Pharmacovigilance and skilled at planning, implementing and overseeing key improvements to drive business growth and efficiency. History of cultivating an open culture with free exchange of information. Pursuing new professional challenges with a growth-oriented company.
Forward-thinking Senior Manager adept at managing teams of 14 employees with direct reports to accomplish challenging objectives. Imparts clear vision to guide cohesive, high-performing teams.
Qualified M.B.B.S, M.BA with proven track record in leading teams and driving operational efficiency. Demonstrated ability to implement strategic initiatives that enhance productivity and foster growth. Known for utilizing strong leadership and communication skills to facilitate team collaboration and achieve organizational goals.
Experienced with strategic planning, team leadership, and operational management. Utilizes comprehensive business acumen to drive efficiency and innovation. Track record of fostering collaborative environments and achieving high-impact results. Versatile Senior Manager specializing in [Area] and skilled at planning, implementing and overseeing key improvements to drive business growth and efficiency. History of cultivating an open culture with free exchange of information. Pursuing new professional challenges with a growth-oriented company.
Overview
21
21
years of professional experience
7
7
years of post-secondary education
4
4
Languages
Work History
Senior Manager-Team Lead
Lupin Ltd.
11.2017 - 05.2024
- Team management
- Managing the Medical Review Team, Literature Team and Clinical Safety Team, which comprised 15 team members, as a Team Lead.
- Leading from the front
- Mentoring the various teams across the function within the Drug Safety Risk Management Department
- Performing the yearly appraisal for the reportee
- Creation of Medical Review Team activities matrix and delegation of the respective activities, with active progress monitoring.
- Giving regular feedback for the activities performed by the team
- Managing the Medical Review (MR) Function, Literature Function and Clinical Safety Function
- Managing the Medical Review team consisting of seven Medical Reviewers.
- Performing the end-year appraisal of the Medical Reviewers.
- Initiation of Individual Case Safety Reports (ICSRs) assignments to the Medical Review Team, followed by monitoring of the progress for target completion.
- Created manually the ICSR cases monitoring, to track the performance of and timelines of the Data Entry Team, Quality Check Team, and followed by Medical Review Team assessment.
- Initiation of Therapeutic-area wise distribution of ICSRs, for a better understanding of the product’s safety profile and expediting the Medical Review of ICSRs with lesser turn-around time and maintaining the regulatory reporting compliance.
- Improvisation towards case processing, by knowledge sharing.
- Introduced the follow-up process for ICSRs processing, with ideation, planning and implementation of Argus action items in to the system.
- Supported the cross-functional team for SOP updates. Example – Narrative SOP, Deletion SOP updates. Triage SOP updates.
- Ideated, Planned and implemented the training sessions for DSRM on topics such as Dechallenge and Rechallenge, Seriousness and Causality, Labelling assessment, AE handling in literature, Processing of pregnancy ICSRs, The signal process, including the training of Empirica Signal Detection System.
- Have managed to lead comparatively inexperienced Medical Reviewers and provide support while doing the Medical Assessment for the documents such as PSURs, PBRER, PSURS, Signal Reports and various other documents as per requirement for the Drug Safety Risk Management Function.
- Have managed to completely reduce the backlog of more than 1000 cases and ensuring that the backlog is not created in the future.
- Have provided ideas for process optimization to improve the speed and accuracy while processing the cases, e.g introduction of ICSRs book-in, creation of priority in safety database, creation of expedited status in safety database as an action item, creation of follow-up in safety database as an action item.
- Setting up the process for deletion of ICSRa, Regulatory intelligence, QC sampling of the ICSR to keep a check on the quality of cases processed.
- Preparing Medical Impact Analysis, e.g for late cases.
- Preparation and review of Non-conformance and CAPA activities.
- Continuous mentoring of the MR team, Case processing team, and Triage team on their performance.
- Creation of the process for Company Core Safety information.
- Creation of evaluation of Lack of Efficacy assessment.
- Creation of Medical reviewer's activities in the form of the matrix.
- Guiding and setting up the process for non-ICSRs, which included planning and implementation of the review from the Literature and Medical Review Team, for various product portfolios within the Company.
- Review and approval of Health Hazard Reports for monitoring drug quality and patient safety.
- Supported the reconciliation team to detect the difference in Product Quality Complaints (alone) or those associated with Lack of efficacy or Product Quality Complaints associated with Lack of efficacy and additional adverse events.
- Preparation of Training Matrix for New Joiners.
- Signal Management
- Introduced quantitative measures for Signal Detection using EmpiricaTM Signal Detection Tool, following which a complete revamp of the Signal Detection process, and update to Signal Management Standard Operating Process (SOP).
- The Empirica Signal Detection System introduction included configuration of the system and continuous discussion with the vendor (Vendor management) for the convenience of the end user, product mapping, data mining runs, medical review of data, and assigning the drug-event combinations for medical review to the team for further medical assessment.
- Created the Comprehensive Signal Assessment report with examples for guidance to inexperienced Medical Reviewers.
- Created the Empirica Work Instruction (Single=Handedly) for ease of use to Medical Reviewers, with screenshot for a single step in use for Signal Detection.
- Created the process for review of eRMR data (ideation, planning and implementation). Followed by an update to Signal Management SOP.
- Have detected three Drug Safety Signals for various molecules, including brand molecules for Lupin. These findings was accepted by PRAC during the Aggregate Review.
- Started Signal Detection Board Meeting for discussion with newly or changed signal, with various stakeholders; globally.
- Created the Signal Review for Company Products, based on risk-based monitoring, which was followed by prioritization of molecules for further monitoring.
- Tracking the signals in Empirica Signal Detection Tool, for further monitoring.
- Setting up, planning, and implementing of the Targeted follow-up questionnaires for Adverse Event of Interest (AOSE), as per Risk Management Plan, Globally.
- Created the document for AOSE for SUSARs, e.g. Investigator Notifications.
- Medical Review of Safety Management Plan, Protocol for Clinical Trials.
- Deputy Pharmacovigilance Officer In-charge (PvOI) – Maintenance of PvMF.
- Non-conformance and Corrective Actions Preventive Actions.
- Identifying non-conformance and timely completion of CAPA activities and its closure and further monitoring of CAPA effectiveness.
- Aggregate Reports.
- Introduced the new format of Health Hazard Assessment.
- Review of Health Hazard Assessment report.
- Initiated the process of Medical Review of the literature to be presented in the Health Hazard Assessment Reports.
- Assignments and tracking of the Aggregate reports, for compliance and quality.
- Review of PSURs, PBRERs and PADERs.
- Continuous mentoring of the Aggregate team authors and quality reviewers.
- Initiated the inclusion of broader search methodology for retrieving cases for Signal reports and Aggregate Reports.
- Review of SmPC and PIL update.
- Individual Case Safety Reports.
- Created manually the ICSR cases monitoring, to track the performance of and timelines of the Data Entry Team, Quality Check Team, and followed by Medical Review Team assessment.
- Initiation of Therapeutic-area wise distribution of ICSRs, for a better understanding of the product’s safety profile and expediting the Medical Review of ICSRs with lesser turn-around time and maintaining the quality and regulatory reporting compliance.
- Introduced the follow-up process for ICSRs processing, with ideation, planning and implementation of action items in to the safety database system.
- Creation of the process for Company Core Safety information.
- Established strong relationships with clients and stakeholders, ensuring long-term partnerships and repeat business.
- Provided strong leadership to enhance team productivity and morale.
- Led cross-functional teams to achieve project milestones and deliver high-quality results.
- Consistently met or exceeded annual performance targets set by senior leadership.
- Collaborated closely with peers from other departments to drive organizational success jointly as one cohesive unit.
- Improved team performance by providing comprehensive training and fostering a collaborative work environment.
- Mentored junior staff members for skill development and career progression within the organization.
- Boosted team member productivity by enhancing performance monitoring and instituting motivational approaches.
- Reviewed and analyzed reports, records and directives to obtain data required for planning department activities.
- Managed large-scale projects and introduced new systems, tools, and processes to achieve challenging objectives.
- Demonstrated exceptional adaptability in navigating complex situations or rapidly changing environments with ease.
- Increased customer satisfaction with timely project deliveries and seamless communication.
- Achieved operational excellence by streamlining processes and implementing best practices.
- Implemented innovative solutions to overcome challenges, leading to enhanced productivity levels.
- Spearheaded change management efforts for seamless adoption of new systems or processes among employees.
- Conducted performance evaluations, compensations and hiring to maintain appropriate staffing requirements.
- Evaluated vendor offerings critically to select the most appropriate partners for delivering desired results at optimal costs.
- Balanced competing priorities efficiently while maintaining focus on critical tasks requiring immediate attention.
- Championed process improvement initiatives that led to significant cost savings without compromising on quality standards.
- Championed company-wide diversity and inclusion initiative, creating more supportive and innovative work environment.
- Improved team productivity by implementing agile methodologies, reducing project completion times and enhancing collaboration.
- Developed and executed successful training program for junior managers, equipping them with essential leadership skills.
- Drove adoption of new technology solutions, modernizing operations and improving operational efficiency.
- Enhanced team performance with regular coaching sessions, focusing on individual strengths and areas for improvement.
- Led market analysis efforts to identify emerging trends, informing strategic decision-making and future investments.
- Led strategic planning sessions to align departmental goals with overall company vision, fostering cohesive growth strategy.
- Implemented risk management framework, mitigating potential threats to project success and company operations.
- Coordinated cross-departmental projects to improve product delivery timelines, enhancing customer satisfaction.
- Evaluated employee performance and conveyed constructive feedback to improve skills.
- Established team priorities, maintained schedules and monitored performance.
- Defined clear targets and objectives and communicated to other team members.
- Maintained positive customer relations by addressing problems head-on and implementing successful corrective actions.
- Recruited, interviewed and hired employees and implemented mentoring program to promote positive feedback and engagement.
- Leveraged data and analytics to make informed decisions and drive business improvements.
- Set aggressive targets for employees to drive company success and strengthen motivation.
- Cultivated positive rapport with fellow employees to boost company morale and promote employee retention.
- Launched quality assurance practices for each phase of development
- Improved staffing during busy periods by creating employee schedules and monitoring call-outs.
- Planned, created, tested and deployed system life cycle methodology to produce high quality systems to meet and exceed customer expectations.
- Opened and closed location and monitored shift changes to uphold successful operations strategies and maximize business success.
- Established performance goals for employees and provided feedback on methods for reaching those milestones.
- Promoted a positive work environment by fostering teamwork, open communication, and employee recognition initiatives.
- Enhanced overall team performance by providing regular coaching, feedback, and skill development opportunities.
- Established clear performance metrics for the team which helped in tracking progress towards set targets effectively.
- Coached team members in techniques necessary to complete job tasks.
- Trained new team members by relaying information on company procedures and safety requirements.
- Influenced positive change within the organization through strategic thinking, innovation, problem-solving abilities, and consistent leadership style.
- Collaborated with other department leads to streamline workflows, improve interdepartmental coordination, and achieve business goals collectively.
- Evaluated employee skills and knowledge regularly, training, and mentoring individuals with lagging skills.
- Served as a role model for the team by demonstrating commitment to excellence, professionalism, and adherence to company values at all times.
- Conducted regular progress reviews with individual team members to identify areas for improvement and provide guidance on career development opportunities.
- Managed schedules, accepted time off requests and found coverage for short shifts.
- Managed risks and mitigated potential issues through proactive planning, monitoring, and timely decisionmaking.
- Worked different stations to provide optimal coverage and meet production goals.
- Established open and professional relationships with team members to achieve quick resolutions for various issues.
- Assisted in recruitment to build team of top performers.
- Conducted regular reviews of operations and identified areas for improvement.
- Evaluated customer needs and feedback to drive product and service improvements.
- Generated reports detailing findings and recommendations.
- Optimized customer experience by delivering superior services and effectively troubleshooting issues.
- Evaluated staff performance and provided coaching to address inefficiencies.
- Created and managed project plans, timelines and budgets.
- Helped meet changing demands by recommending improvements to business systems or procedures.
- Maintained database systems to track and analyze operational data.
- Developed effective improvement plans in alignment with goals and specifications.
- Maintained overall safe work environment with employee training programs and enforcement of safety procedures.
- Devised and implemented processes and procedures to streamline operations.
- Gathered, organized and input information into digital database.
- Collected, arranged, and input information into database system.
- Educated staff on organizational mission and goals to help employees achieve success.
- Observed packing operations to verify conformance to specifications.
- Supported creation of detailed, technical financial models to value potential acquisition targets.
- Frequently inspected production area to verify proper equipment operation.
- Cultivated positive relationships with vendors to deliver timely and cost-effective supply of services and materials.
Senior Pharmacovigilance Expert
Novartis Healthcare Pvt. Ltd.
10.2011 - 05.2016
- Assigned Product Portfolio
- Development Products
- Therapeutic Class
- Indication
- Clinical Trial Phase
- Tropical Medicine
- Drug-Resistant Malaria
- Phase I and II
- Matured Products
- Therapeutic Area
- Indication
- Products
- Tropical Medicines
- Antimalarials
- Artemisinin Based Combination
- Anti-Leprosy
- Lameprene
- Psychiatry
- Antipsychotics
- Clozapine
- Antidepressants and Anxiolytics
- Tricyclic Antidepressants and SSRIs
- Neurology
- Anti-epileptic
- Oxcarbazepine and Carbamazepine
- ADHD
- Methlyphenidate
- Multiple Sclerosis
- Baclofen
- Respiratory medicines
- Asthma and COPD
- Formoterol/Budesonide, Theophylline
- Metabolic disorder
- Dyslipidemic
- Fluvastatin
- Pain
- Diclofenac
- Medical review of single cases/case correction
- Medical assessment and related activities for single cases for priority products, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of line listings of single cases, and preparation of investigator notifications.
- Additionally, quality check, compliance and mentoring outsource ICSR processing.
- Review of locked serious case listings on daily basis for assigned product to identified potential safety signals.
- Reviewing the guidance document for the processing of ICSR for the assigned products.
- Literature review
- Performing a comprehensive review of the medical and scientific literature [(both manual and through Literature search application (LiSA)] on daily basis, to identify the following information:
- New or changing signals and their impact on benefit-risk profile of the product.
- Off-label use, pregnancy, overdose, medication error, drug abuse/misuse, product quality defects, drug interaction, lack of efficacy, class effects.
- New or changing information on RMP risk, PSUR safety topics.
- Identifying/confirming valid ICSR from published literature.
- Investigator Notification for SUSAR (INDICSR).
- Evaluation and assessment of ICSR for SUSAR and drafting the Investigator Notification if the SUSAR criteria are met.
- Informing the cross-functional teams regarding the Investigator Notification for their review.
- Initiating follow-up for medical review of INDICSR.
- Signal Detection and Management (Regular and on ad-hoc basis).
- Identification, Evaluation, Escalation, and monitoring of safety signals - Independent identification of new or changing signals using the below mentioned methods.
- Independent presentation of new or changing signals to cross-functional teams, specialized safety boards and EU-QPPV (when necessary) for review and endorsement of the action plan, including signal impact assessment.
- ICSR/cluster of cases along with noteworthy case.
- Data mining reports.
- Abnormal lab findings.
- Class effects.
- Preclinical study findings.
- Clinical study findings.
- Health Authority request.
- Literature.
- Review of Standard textbooks.
- Product technical or quality complaints.
- Market exposure.
- Signal detection through EMPIRICA signal detection tool.
- Periodic Benefit Risk Evaluation Report (PBRER/PSUR).
- Leading all PSUR related activities. Authoring, analyzing and reviewing the multiple PBRERs, independently, in a timely manner and with high quality.
- The following activities were performed.
- Leading the scientific discussion in kick-off meeting and subsequent meetings.
- Preparing strategies, providing scientific guidance to medical writer and to keep oversight on overall progress of outsourced PBRER activities.
- Compiling and formalizing safety topics based on various sources e.g. RMP, Health Authority assessment report.
- Organizing safety topics as per GVP requirements under various PSUR sections.
- Authoring and review of relevant PBRER sections, including risk-benefit evaluation.
- Quality check of the final PBRER and QC scoring of the outsourced PSUR.
- Core Safety Data Sheet/Labelling updates.
- Taking lead in all the activities pertaining to CDS updates for assigned product portfolio.
- The following activities were performed.
- Analyzing the deviations of CDS from various local country labels, competitor labels, similar class labels and standard textbooks.
- Drafted the clinical expert statement to provide the rationale for inclusion or non-inclusion in the safety sections of the CDS and taking approvals from various boards.
- Clinical Study Protocol, Clinical Study Report and Investigator Brochure Review.
- Review of clinical study design, inclusion exclusion criteria and regulatory safety reporting.
- Review of IB for appropriateness, consistency, accuracy, completeness, and to ensure the information is presented in a clear, concise, objective, balanced, and non-promotional manner.
- Development Safety Profiling Plan authoring and reviewing.
- Involved in authoring and providing inputs during the updates of Development Safety Profiling Plan for the Phase I and Phase II products.
- Health Authorities Query Response.
- Taking lead in responding to Health Authorities queries on Core Data Sheet, PSUR, Risk Management Plan; by drafting comprehensive Clinical Expert Statement.
- Drug Withdrawals, drug stock-out issues and Out-of-Specification results.
- Leading the activities of above mentioned issues and drafting the expert statement to evaluate the safety impact of these issues.
- Making the decision with involvement of cross-functional teams whether to stop manufacturing or distribution of drug batches in case of out-of-specification results.
- Inspections from Health Authorities.
- Successfully faced interview with FDA inspector.
- Training and Mentoring.
- Providing on-board training and mentoring to the junior staff or new recruitment in drug safety department.
- License renewal and deregistration of products.
- Leading the safety team in activities pertaining to license renewal and deregistration of products.
- Other Activities.
- Created guidance document or format for evaluation of antimicrobial resistance so as to standardize the approach for all the antimicrobials across the team.
- Created guidance document or format for evaluation of out-of-specification results for standardized approach across the teams.
- Supported audits and inspections by providing necessary documentation and showcasing adherence to established pharmacovigilance procedures.
- Mentored junior staff members, enhancing their skills and knowledge within the field of pharmacovigilance.
- Conducted detailed signal detection activities to proactively identify emerging safety trends in marketed products.
- Maintained up-to-date knowledge of global regulations and guidelines related to pharmacovigilance practices.
- Contributed to quality improvement initiatives within the department, driving continuous enhancements to pharmacovigilance operations.
- Evaluated new technologies and tools for better management of drug safety data within the organization.
- Coordinated with medical writing teams for accurate representation of safety data in regulatory documents.
- Proactively addressed potential discrepancies in adverse event reporting through thorough investigation and resolution efforts.
- Managed timelines effectively, ensuring timely completion of critical deliverables within the realm of pharmacovigilance responsibilities.
- Contributed to the development of standardized operating procedures, ensuring a consistent approach to pharmacovigilance tasks across the organization.
- Minimized risk to patients by promptly identifying and addressing potential safety concerns with medications.
- Assisted in the preparation of periodic safety update reports, providing comprehensive reviews of product safety data.
- Collaborated with cross-functional teams for seamless integration of pharmacovigilance systems in clinical trials.
- Enhanced drug safety monitoring by conducting comprehensive case analyses and assessments.
- Established effective communication channels across departments for efficient information flow related to product safety concerns.
- Played a key role in the implementation of risk management plans, mitigating potential medication-related risks.
- Improved adverse event reporting accuracy through rigorous data validation and trend analysis.
- Developed strong working relationships with health authorities, ensuring prompt communication of safety updates.
- Authored and managed regular safety update reports.
- Conducted case reconciliation with internal departments, distributors, affiliates and business partners.
- Responded to requests from regulatory agencies and notified to share information.
- Supported inspections, visits and audits as well as CAPAs management.
- Oversaw adverse events case reporting and conducted follow-up.
- Developed new or improved pharmacovigilance procedures.
- Monitored deliverables for quality and adherence to regulatory reporting timelines.
- Evaluated safety profiles, wrote signal detection reports and monitored document filing and archiving.
- Trained staff and updated training documents to meet regulations and standards.
- Read scientific literature and bibliographic sources.
- Reported problems and concerns to management.
- Reviewed production processes and identified potential quality issues.
- Conducted data review and followed standard practices to find solutions.
- Liaised between quality control and other departments and contractors, providing project updates and consultation.
Medical Review Safety Physician
Accenture Services Pvt. Ltd.
07.2010 - 10.2011
- Medical review of single cases/case correction.
- Handling triage of cases as regulatory/ non-regulatory based on the medical assessment.
- Identifying and reporting the safety reports as per the SOP and PVG guidelines.
- Provide a medical evaluation comment for adverse events as needed for ICSR.
- Reviewing and verifying appropriate selection of adverse events from source documents, appropriate MedDRA code for each adverse event and accuracy of label assessments for each adverse event.
- Assessing causality for Adverse Events in Clinical Trial Cases, Spontaneous Cases and Solicited Reports; providing medical evaluation comment for adverse events as needed for ICSR (Spontaneous).
- Reviewing source document for assuring medical accuracy in the information pertaining to various cases and the data entered into Global Safety Database.
- Maintaining consistency between source documents and narrative summary.
- Following up adverse events for obtaining information and reviewing letters and queries for appropriateness and completeness.
- Coordinating and participating in daily review & weekly surveillance meetings for closely monitoring potential safety signals.
- Studying literature articles on products marketed/ under development by the company.
- Forwarding relevant case reports or articles to the Medical Information and other relevant groups, and studying potential medical/ safety implications with regard to the company's products.
- Undertaking signal generation and other risk benefits evaluation.
- Ensuring adherence to regulatory reporting as per the International timelines.
- Attending meetings on Client Service Level Agreements based on the quality and operations.
- Assisting the team for meeting technical and operations challenges.
Medical Monitor and Senior Clinical Research Associate
inVentiv International Pharma Services
03.2009 - 06.2010
- Overseeing and Managing Clinical and Medical operations at the project level.
- Acted as a Team Leader in assisting the Preparation of study budget mainly related to Site Cost, Lab Cost and Clinical Trial Supply Management Cost.
- Trained the study team on protocol requirements; trained the staff through therapeutic area training with respect to projects running under clinical operations and market research.
- Reviewing the reports of CRAs and mentoring CTAs.
- Innovating new Monitoring tracking tools as per the Clinical studies.
- Overseeing of the conduct of feasibilities, developing the potential Investigators Database and selecting the potential investigator.
- Assisting sponsor in the development of Protocol for Clinical Studies.
- Conducted Site Evaluation, Site Initiation, Site Monitoring and Site Close Out Visits and its related activities like preparation of the report, post visit follow up, etc.
- Reviewed the subject’s medical parameters, lab reports and the relation for reporting the same to AE/ ADR and SAE; reviewed temporal relationships stated in ADRs.
- Reviewed AE and SAE reports for adequacy and their timely reporting to regulatory authorities.
- Overseeing of the Ethics Committee Dossier for submission.
- Reviewing Monitoring Plan.
- Assisted site to form Ethics Committee and developing Ethics Committee SOPs.
- Negotiated with Investigator Grant and ensured the release of the grants on a timely manner; ensured that the study metrics are tracked and communicated.
- Ensure site compliance with the Protocol, GCP and local regulatory requirements.
- Prepared Regulatory Dossier for submission to DCGI as per the guidelines and reviewed the documents provided by the sponsor as per the DCGI guidelines/ schedule.
- Assisted in developing India-specific Regulatory SOPs and in preparing the proposals.
- Developed of the database of the Key Opinion Leaders (KOL’s) in the field of the Nutrition and coordinated with them to understand the demands of patients of different age groups in the field of Nutrition.
- Assisted Sponsor in understanding the demands of the Indian patients/population related to the field of nutrition and providing an appropriate vision to Sponsor for the development of the products.
- Evaluated incoming trial proposals for feasibility, scientific validity, and alignment with organizational goals before recommending approval or rejection.
- Improved trial efficiency through thorough review of study protocols and providing timely feedback to investigators.
- Strengthened internal processes by participating in process improvement initiatives, incorporating lessons learned from past experiences into future projects.
- Contributed to the development of clinical study reports, presenting clear and concise data analysis results.
- Mentored junior team members, fostering a supportive work environment that encouraged professional growth.
- Collaborated with cross-functional teams for successful implementation of complex clinical studies.
- Promoted effective communication between stakeholders by organizing and leading regular project meetings.
- Provided medical expertise to study teams, assisting in the design of scientifically sound clinical trials.
- Ensured regulatory compliance by maintaining up-to-date knowledge on guidelines and applying them in protocol development.
- Streamlined processes by creating standardized templates for review forms and other essential documents, reducing redundancies and errors.
- Assisted with the preparation of scientific presentations for conferences, showcasing the organization''s research findings to industry professionals.
- Led efforts to develop comprehensive risk mitigation strategies while maintaining a focus on patient welfare.
- Supported site staff during inspections, ensuring proper documentation and adherence to regulations.
- Reviewed adverse event data, identifying trends and potential safety signals that warranted further investigation or action.
- Participated in investigator training sessions, ensuring a consistent understanding of study objectives among all involved parties.
- Developed relationships with key opinion leaders in relevant therapeutic areas, promoting collaboration and exchange of ideas within the medical community.
- Monitored inventory levels of supplies, equipment, and reagents used and placed orders for replacements.
- Interacted with patients and families while demonstrating high standards of performance, teamwork, and compassion.
- Maintained patient records and reports to enable tracking history and provide accurate and up-to-date information for physicians and other medical staff.
- Maintained patient confidence and protected hospital by keeping information confidential.
- Assisted physicians and nurses in performing diagnostic tests and procedures to identify accurate treatment for patients.
- Measured patient vital signs such as blood pressure, pulse rate, and temperature to record information on patients' charts.
- Performed patient service duties by communicating directly with patients, answering questions, and assisting with concerns.
- Collected and processed laboratory specimens to obtain samples for analysis.
- Monitored patient vital signs, lab results and other indicators of health.
- Operated and maintained medical equipment used to diagnose and treat patients.
- Maintained accurate patient charts and medical records.
- Evaluated patient histories and medical records for accuracy and completeness.
- Educated patients about procedures, answered questions, and provided comforting words to control anxiety and enhance procedure results.
- Performed diagnostic tests and reported results to healthcare providers.
- Gathered, charted, and analyzed patient history data and discussed key points with clinicians.
- Cared for patients by providing personal assistance and ambulation.
- Participated in hospital and clinic staff meetings to discuss patient care.
- Triaged patients in office or by phone to assess severity of conditions.
- Called patients post-procedure to inquire about status, recovery and questions.
- Instructed patients in at-home care and continued treatments.
- Educated patients and caregivers on proper ways to use breathing apparatuses at home.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Guided development of adaptive systems framework that integrated data from multiple sources to augment training and operational performance.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Achieved project objectives by troubleshooting experiments and testing practical and creative solutions.
- Designed and executed studies to support usability of solutions, analyze data and provide actionable recommendations to project team.
- Assisted in budget planning and forecasting for clinical research projects, optimizing resource allocation while maintaining high-quality standards.
- Designed effective training materials for site personnel, enhancing understanding of study procedures and expectations.
- Improved clinical trial efficiency by streamlining data collection and management processes.
- Mitigated risks to subject safety or study integrity by promptly identifying issues during site visits and implementing corrective actions as necessary.
- Contributed to the development of study protocols, informed consent forms, and case report forms to ensure consistency across clinical trials.
- Reduced study timelines by effectively managing multiple concurrent clinical trials across various therapeutic areas.
- Strengthened collaboration with cross-functional teams, ensuring clear communication and alignment on project goals.
- Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
- Played an instrumental role in driving enrollment success by collaborating closely with sites on recruitment strategies tailored to specific patient populations.
- Advanced the organization''s clinical research capabilities by staying abreast of industry trends, attending relevant conferences, and sharing learnings with colleagues.
- Enhanced patient safety through meticulous monitoring of adverse events and protocol compliance.
- Optimized study startup times by proactively addressing potential bottlenecks and refining site selection criteria.
- Streamlined vendor management processes for more efficient service delivery in support of clinical trial activities.
- Increased the accuracy of study data by implementing robust quality control measures during data review and analysis phases.
- Supported regulatory submissions with comprehensive documentation preparation, leading to successful approval of investigational products.
- Facilitated seamless transitions between study phases through proactive planning, coordination, and communication with internal stakeholders.
- Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout the study duration.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Followed informed consent processes and maintained records.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
Clinical Research Associate
Max Neeman Intl
10.2007 - 03.2009
- Undertaking site feasibility, site selection and trial allocation.
- Assessing the ability to meet study timeline, the resource necessary to do the study and financial feasibility of performing the study.
- Creating & reviewing study specific source document like medical records, & other study material.
- Maintaining documentation, compiling & analyzing patient’s database & ensuring accuracy, completeness, legibility & timeline to the database.
- Coordinating with the other departments, ensuring smooth and profitable operations.
- Submitted the trial related documents to the Ethics Committee for approval.
- Carried forward the study related procedures in compliance with the protocol and ICH GCP.
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
Medical Officer
Mathadi Hospital Trust
05.2003 - 04.2006
- Worked in Medical, Surgical, Obstetrics-Gynecology departments; along-with handling the outpatient departments.
- Monitored patient progress and adjusted treatments accordingly.
- Improved patient outcomes by implementing evidence-based medical practices and protocols.
- Improved patient outcomes and delivery of care through improved clinical quality processes.
- Enhanced patient satisfaction with thorough assessments, diagnoses, and treatment plans.
- Mentored junior medical staff members through hands-on training sessions, reinforcing key concepts and guiding their professional growth.
- Interpreted diagnostic test results for deviations from normal.
- Reviewed complex cases alongside colleagues during peer consultations to develop consensus on appropriate courses of action for challenging scenarios.
- Promoted a culture of safety within the healthcare facility, adhering to strict infection control measures and reporting potential hazards.
- Applied continuous process improvement strategies to enhance case management, programs and clinical management.
- Facilitated seamless transitions of care for patients by coordinating with physicians, nurses, and other healthcare professionals across various departments.
- Verified complex diagnoses to facilitate treatment plans.
- Participated in ongoing professional development opportunities to stay current with advances in medicine and enhance clinical skills.
- Served as an approachable resource for patients'' families, addressing concerns and providing education on medical conditions and treatments.
- Advocated for patient-centered care within the healthcare facility by championing initiatives that cater to individual needs and preferences.
- Collaborated with interdisciplinary teams to optimize patient care and streamline communication.
- Led diverse team of medical and administrative professionals in day-to-day clinic activities such as patient care, new business development, and patient relations.
- Established partnerships with community organizations to improve access to preventive healthcare services and enhance overall population health.
- Streamlined documentation processes, ensuring accurate, timely, and comprehensive medical records for improved continuity of care.
- Coordinated with multidisciplinary teams to develop comprehensive care plans for patients with complex health needs.
- Enhanced patient outcomes by implementing innovative treatment protocols.
- Conducted comprehensive medical examinations to ensure accurate diagnosis and effective treatment planning.
- Improved patient satisfaction with personalized care and attention to detail.
- Enhanced departmental performance by mentoring junior medical officers and sharing best practices.
- Contributed to development of hospital policies and procedures, ensuring compliance with healthcare regulations.
- Discussed medical histories with patients in effort to provide most effective medical advice.
- Communicated with patients, ensuring that medical information was kept private.
- Implemented successful healthcare program through professionalism, quality of care, medical teaching and patient satisfaction.
- Established and maintained effective communication with staff, physicians and community organizations to promote high quality patient care.
- Liaised with other healthcare professionals to develop comprehensive patient care plans and provide highest quality of care.
- Monitored and inspected staff processes to eliminate hazards posed for both residents and staff while ensuring continuous compliance with regulations.
Education
MBBS -
Mumbai University
01.1996 - 01.2002
Masters of Business Administration - undefined
University of Northampton
01.2016 - 01.2017
Skills
Operational Acumen
Team Leadership
Situational Leadership
Communication
Innovative Thinking
Relationship Management
People Management
Managerial Skills
Planning
Coordination
Analytical Skills
Problem-Solving Skills
Technical Acumen
Signal Management (Qualitative and Quantitative measures)
Expert in Empirica Signal Detection Tool
Deputy Pharmacovigilance Officer Incharge (PVOI)
Experience in Non-conformance and Corrective and Preventive Action Plan (NC-CAPAs)
Experience in handling Internal, External Audits and Inspection
Experience in auditing for vendor selection
Aggregate report review (PBRER, PSUR, PADERs, ACO, Health Hazard Assessment reports, RMP)
Managed the ICSR Medical Review Workflow in Company Safety Database, including performing medical review of ICSR
Responding to Health Authorities queries eg, PRAC rapporteur queries
Personal Information
Date of Birth: 03/30/79
Rewards And Recognition
- Top performer in Lupin Limited
- Handled USFDA inspection with no 483
- Multiple appreciation awards in Novartis Healthcare Pvt Ltd
- Idol of Month at inVentiv International Pharma Services
Timeline
Senior Manager-Team Lead
Lupin Ltd.
11.2017 - 05.2024
Masters of Business Administration - undefined
University of Northampton
01.2016 - 01.2017
Senior Pharmacovigilance Expert
Novartis Healthcare Pvt. Ltd.
10.2011 - 05.2016
Medical Review Safety Physician
Accenture Services Pvt. Ltd.
07.2010 - 10.2011
Medical Monitor and Senior Clinical Research Associate
inVentiv International Pharma Services
03.2009 - 06.2010
Clinical Research Associate
Max Neeman Intl
10.2007 - 03.2009
Medical Officer
Mathadi Hospital Trust
05.2003 - 04.2006
MBBS -
Mumbai University
01.1996 - 01.2002