Sumit Kumar
Mumbai
Summary
Dynamic and results-driven manager with a proven track record in leadership, strategic planning, and process optimization. Skilled in team development, operational efficiency, and driving productivity through innovative solutions. Adept at fostering collaboration, improving performance, and implementing effective strategies to meet business objectives. Strong communicator and problem-solver, with a commitment to excellence in fast-paced, deadline-driven environments.
Overview
14
14
years of professional experience
Work History
Manager-Pharmacovigilance
Eisai Pharmaceuticals India Pvt Ltd
Mumbai
04.2023 - Current
- Responsible for pharmacovigilance activities in the Asia region, and establishing and maintaining the pharmacovigilance system for products marketed in India, Sri Lanka, and Bangladesh.
- To ensure compliance with legal requirements, and oversee the functioning of the system.
- Providing oversight of the pharmacovigilance quality system, including standard operating procedures, contractual arrangements, and compliance data.
- Reviewing and approving changes to the pharmacovigilance system.
- Preparation and finalization of PV agreements between the company and third parties.
- Participate in global teleconferences and face-to-face meetings, as required.
- Implemented quality control measures to uphold company standards.
- Negotiated contracts and agreements with vendors and suppliers to reduce costs.
- Reviewed completed work to verify consistency, quality, and conformance.
- Managed risk by developing and implementing effective risk management strategies.
- Produced thorough, accurate and timely reports of project activities.
- Ensured compliance with regulatory requirements and industry standards.
- Managed vendor relationships by negotiating contracts and ensuring timely delivery of goods and services.
- Completed day-to-day duties accurately and efficiently.
- Worked with cross-functional teams to achieve goals.
- Preparation of local RMPs and PSURs.
- Submission of Periodic Safety Update Reports (PSURs) to the regulatory authorities, according to regulations and standard operating procedures.
- Preparation of training material and providing pharmacovigilance training (induction and refresher) to internal staff and external partners, as required.
Assistant Manager-Pharmacovigilance
Eisai Pharmaceuticals India Pvt Ltd
Mumbai
09.2020 - 03.2023
- Responsible for pharmacovigilance activities in the Asia region, and establishing and maintaining the pharmacovigilance system for products marketed in India, Bangladesh, and Sri Lanka.
- Responsible for the creation of a pharmacovigilance system in the organization.
- Actively participate in departmental and various cross-functional projects that may include regulatory, sales and marketing, and medical affairs.
- Ensure data accuracy, clinically valid case assessment, regulatory reporting status assessment, and ensure follow-up is completed on pharmacovigilance cases.
- Report adverse events to the appropriate regulatory authorities and clinical study personnel according to regulations and standard operating procedures.
- Submission of Periodic Safety Update Reports (PSURs) to the regulatory authorities, according to regulations and standard operating procedures.
- Maintain a log, compliance information, and a filing system for all PV cases.
- Preparation of PV SOPs and working instructions, as required.
- Preparation and finalization of PV agreements between the company and third parties
- Participate in global teleconferences and face-to-face meetings, as required.
- Preparation of training material and providing pharmacovigilance training (induction and refresher) to internal staff and external partners, as required
- Coordinated with other departments to ensure smooth flow of operations.
- Preparation of local RMPs and PSURs.
Team Leader
Cognizant Technology Solutions Pvt Ltd
Kolkata
08.2019 - 07.2020
- To supervise and coordinate all project-related activities.
- Communicate between the project manager and team
- Record, maintain, and track metrics for both team members and project performances.
- Following up with sites regarding outstanding queries and the reconciliation of discrepancies, maintaining the data as per client-specific SOPs and guidelines.
- Leave and workflow management.
- Attend training sessions, and develop capabilities on an ongoing basis.
- Preparation of a performance report, as required.
- Discussion of IT-related issues and their impact on a client call.
- Responsibilities for monitoring the regional hubs in boxes for case intake, and ensuring all emails are triaged and auctioned properly.
- Conducted regular performance evaluations, providing constructive feedback and personalized coaching.
- Organized client meetings to provide project updates.
- Managed conflict resolution within the team to maintain a positive work environment.
- Maintained a positive work environment that promoted collaboration between team members.
- Offered training and support to keep team members motivated and working toward objectives.
- Conducted regular performance reviews to assess individual team member progress.
- Oversaw quality control to identify inconsistencies and malfunctions.
- Developed and monitored key performance indicators (KPIs) to assess team effectiveness.
Project Coordinator
Sciformix Technologies Pvt Ltd
Pune
03.2018 - 05.2019
- Implement and promote the use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables
- Ensure the compliance of operations with governing regulatory requirements
- Create, maintain, and assume accountability for a culture of high customer service.
- Assist the team lead, project manager, or service delivery manager in overall project management, and execute drug safety data management processes.
- A combination of medical coding, narrative writing, peer review, and a case follow-up report.
- Preparation and submission to regulatory authorities, workflow management, identifying quality error trends, and conducting refresher training.
- Assist the team project manager or service delivery manager in resource allocation within the project.
- Assist and coordinate to ensure management volume peaks.
- Assist the project manager or service delivery manager in managing day-to-day operations.
- Identified training needs for team members in order to keep them up-to-date on the latest industry trends.
- Identified project needs by reviewing project objectives and schedules.
- Review of training files for the respective team members.
- Additionally, perform project-specific activities, like training and training documentation-related activities, as per project requirements.
Senior Safety Data Analyst
Sciformix Technologies Pvt Ltd
Pune
01.2016 - 02.2018
- Implement consistent, efficient, and quality processes to meet timelines and deliverables, according to requirements and standard operating procedures.
- Ensure the compliance of operations with governing regulatory requirements.
- Create, maintain, and assume accountability for a culture of high customer service
- Execute drug safety data management processes—a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, case follow-up, report preparation, and submission to regulatory authorities—with accountability for the quality and timeliness of deliverables, and responsibility for process improvements.
- Perform any other support activities as assigned, including tracking various types of information and metrics, ongoing QC of defined process steps, training, and reconciliation of data from multiple sources, including literature searches.
- Conducted root cause analysis for SOP deviations, identified contributing factors, and developed appropriate corrective action plans.
Safety Data Analyst
Sciformix Technologies Pvt Ltd
Pune
06.2013 - 12.2015
- To implement and promote the use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.
- To ensure compliance of operations with governing regulatory requirements, create, maintain, and assume accountability for a culture of high customer service.
- To execute drug safety data management processes, a combination of case intake, triage, case entry, medical coding, narrative writing, peer review, call intake, case follow-up, report preparation, and submission to regulatory authorities is required.
- To perform any other support activities as assigned, including tracking various types of information and metrics, ongoing QC of defined process steps, training, and reconciliation of data from multiple sources, including literature searches.
Junior Data Analyst
Cognizant Technology Solutions Pvt Ltd
Mumbai
07.2011 - 05.2013
- Identification of adverse events, serious adverse events, medication errors, product complaints, and special case scenarios, and working on them accordingly.
- Assess and process all ICSR case types, like Spontaneous, Solicited, Clinical trial, and legal.
- Prepare initial and follow-up case narratives.
- QC of cases and AEM report forms for any kind of error.
- Completion of the data from source documents, including a narrative (narrative writing), complete detailing of the adverse event, selection of the event term, concomitant medications, and medical history against source documents.
Education
Advanced Postgraduate Diploma in Clincal Research And Management -
Jaipur National University
Hyderabad01.2011
Master of Pharmacy -
SRM University
Chennai01.2010
Bachelor of Pharmacy -
Allahabad Agricultural Institute
Allahabad01.2008
Skills
- Pharmacovigilance
- Adverse event (AE) reporting
- Regulatory compliance
- Risk Management Plans (RMP)
- Periodic Safety Update Reports (PSUR)
- FDA regulations
- CAPA management
- Audit management
- Internal and external audits
- Project management
- Operations management
- Product management
- Team management
- Cross-functional collaboration
- Quality control
- Training development
- Training
- Mentoring
References
Available upon request.
Disclaimer
I declare that the information provided in this CV is accurate to the best of my knowledge. I take full responsibility for its contents.
Languages
- English
- Hindi
Personal Information
Marital Status: Married
References
References available upon request.
Timeline
Manager-Pharmacovigilance
Eisai Pharmaceuticals India Pvt Ltd
04.2023 - Current
Assistant Manager-Pharmacovigilance
Eisai Pharmaceuticals India Pvt Ltd
09.2020 - 03.2023
Team Leader
Cognizant Technology Solutions Pvt Ltd
08.2019 - 07.2020
Project Coordinator
Sciformix Technologies Pvt Ltd
03.2018 - 05.2019
Senior Safety Data Analyst
Sciformix Technologies Pvt Ltd
01.2016 - 02.2018
Safety Data Analyst
Sciformix Technologies Pvt Ltd
06.2013 - 12.2015
Junior Data Analyst
Cognizant Technology Solutions Pvt Ltd
07.2011 - 05.2013
Advanced Postgraduate Diploma in Clincal Research And Management -
Jaipur National University
Master of Pharmacy -
SRM University
Bachelor of Pharmacy -
Allahabad Agricultural Institute
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