ARGUS 84
Praveen Nanhore
Safety Operations Workflow Lead
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Experienced professional with a Master's Degree in Pharmacy (Pharmacology) and over 12 years of expertise in the field. Willingness to take on added responsibilities to meet team goals. Adept at directing work of completion consultants and completion supervisors. Successful introducing lean process to increase productivity and cut costs of completion. Well organized, attentive to detail and vigilant in achieving safety and environmental impact reduction objectives. Key competencies include managing and processing expedited adverse events in adherence to regulatory standards and established timelines. Skilled in preparing individual case reports, assessing benefit-risk, detecting safety signals, and interpreting aggregate safety data. Proficient in producing medical safety documents, including pharmacovigilance plans and risk assessment documents, and effectively communicating potential safety issues. Personal traits include an innovative mindset, strong ownership drive, dependability, and accountability. Proactively taken initiative and serves as a motivator and mentor to colleagues. Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success.
Overview
17
17
years of professional experience
7
7
years of post-secondary education
4
4
Certifications
2
2
Languages
Work History
Safety Operations Workflow Lead
IQVIA
Thane
01.2021 - Current
- Partnered with vendors and suppliers to effectively manage and budget.
- Established positive and effective communication among unit staff and organization leadership, reducing miscommunications, and missed deadlines.
- Identified and resolved unauthorized, unsafe, or ineffective practices.
- Set, enforced, and optimized internal policies to maintain responsiveness to demands.
- Responsible for day-to-day work, process flows and constantly endeavoring to be able to lead team from front.
- Responsible for ensuring 100% compliance towards people practice and processes.
- Identify training and development needs of staff in collaboration with training team and safety management.
- Ensured completion of training plan for project across locations. • Allocation and tracking of cases sent on day-to-day basis for project.
- Handling teams with core responsibility of ensuring that Service level agreements (SLA) for teams are met, managing overall workflow of team to ensure that work is completed within regulatory timelines, and ensuring there are lesser complaints and breaches
- Timely Metrics capture. Setting benchmarks for team.
- Ensure appropriate distribution of work among direct reports.
- Mentoring and coaching of team on regular basis or as required.
- SOP Review Committees.
- Contribute to, implement, and support operational decisions as determined and instructed by senior management.
- Manage Safety Operations staff in accordance with organization's policies and applicable regulations.
- Ability to independently engage customers on escalation and scope expansion.
- Responsible for ARGUS development activities for clients, and involving in multiple activities of database validation like Conference Room Pilot (CRP), Operational Qualification Testing (OQ), Installation Qualification testing (IQ) and Performance Qualification Run (PQ Run) activities.
- Mentored and managed team of safety specialists and enforced safety protocols among associates
- Led improvement initiatives to advance operational efficiencies.
Data Analyst Trainer
Cognizant Technology Solutions
Mumbai
12.2013 - 12.2020
- Provided coaching and mentoring to employees.
- Worked with vendors to customize courseware to accommodate business needs.
- Facilitated virtual, in-person and blended learning sessions.
- Analyzed and evaluated training effectiveness and program outcomes.
- Trained and mentored new personnel hired to fulfill various roles.
- Designed and delivered web-based, self-directed learning materials.
- Participated in team projects, demonstrating ability to work collaboratively and effectively.
- Processed cases (ICSR), performed Medical Dictionary for Regulatory Activities search for coding, labeling of adverse events, review, and processing of Safety data.
- Maintenance of CAPA records for audits and assured appropriate closure within agreed timeframe. Reviewing of deviation memos in team and submitting same to compliance team.
- Prioritization and organization of daily workload with team to maintain regulatory compliance and quality standards.
- Other responsibilities included managing overall wellbeing of new joiners, like managing leaves, administration work for team provide input and review relevant safety tracking systems for accuracy and quality and keeping team always motivated to meet desired goals.
- Identified workers with specific skill sets to recommend for promotions or raises, increasing internal hiring.
- Conducted needs assessments to identify gaps in performance and develop targeted learning solutions
- Built and maintained professional relationships with vendors and suppliers
Senior Drug Safety Associate
Tata Consultancy Services
Vikhroli
05.2012 - 12.2013
- Maintained awareness of performance metrics to remain within established limits.
- Reviewed ancillary documentation to identify information for processing and electronic capture.
- Compared adverse event source documents against safety database screens for transcription and medical accuracy.
- Communicated with internal or external contacts to resolve issues related to case processing.
- Passionate about learning and committed to continual improvement.
- Ensured to meet quality standards per project requirements.
- Ensured to meet productivity and delivery standards per project requirements.
- Ensured compliance to all project related processes and activities.
- Excellent attention to detail and accuracy; maintain high quality standards.
- Handling of adverse event product quality complaint issues, reviewing daily and monthly PQC reports.
- Reviewing of deviation memos in team and submitting same to compliance team.
- Navigated intricacies of drug safety databases to process adverse event reports
Clinical Research Coordinator
Shrikrishna Hrudayalaya & Critical Care Centre
Nagpur
05.2011 - 05.2012
- Followed informed consent processes and maintained records.
- 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.
- Gathered, processed, and shipped lab specimens.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Maintained Trial Master File.
- Resolving data queries on Data Clarification Forms (DCFs).
- Participated in Investigational Review Board submission & Approval.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
-
Lecturer
Anurag College Of Pharmacy, Warthi, Bhandara
Bhandara
04.2007 - 06.2009
- Used variety of learning modalities and support materials to facilitate learning process and accentuate presentations.
- Evaluated and revised lesson plans and course content to achieve student-centered learning.
- Mentored and advised students to explore career pathways based and amplify knowledge, skills and strengths.
- Arranged syllabus, developed schedule, and determined reading list for varied courses simultaneously, giving students appropriate time to complete assignments and absorb information.
- Developed and implemented innovative teaching strategies to engage students in lectures and coursework.
- Participated and led committee meetings to remain aware of developments in subject.
- Lecturer's Pharmaceutical Chemistry, Biochemistry & Health Education and Community Pharmacy.
- Officer in-charge for Maharashtra State Board of Technical Education (MSBTE) Examinations handling 2500 students from various streams.
- Permanent APTI ( Association of Pharmaceutical Teachers of India) Member.
- Assessed students' progress and provided feedback to enhance learning
- Built strong rapport with students through class discussions and academic advisement
- Graded quizzes, tests, homework, and projects to provide students with timely academic progress information and feedback
- Led seminars and workshops to facilitate student learning and engagement and increase memory retention
Education
Master of Pharmacy - Pharmacology
Institute of Pharmaceutical Education And Research
Wardha 06.2009 - 06.2011
Bachelor of Pharmacy - Pharmacy
Smt. Kishoritai Bhoyar College of Pharmacy
Kamptee 06.2002 - 06.2007
Skills
Interpersonal Communication
Software
ARISg
Sapphire
Certification
Leadership Skills - Indian Institute of Management Ahmedabad https://coursera.org/verif y/DADERGGQEDZ8
Interests
Reading Books Non-Fiction
Reading Books, University level cricket.
- I have keen interest in Geo-politics and have read books like
- The Ultimate goal, by Vikram Sood,
- The India way, Strategies for an Uncertain world, by Dr. S. Jaishankar.
Additional Information
Honors & Awards
- Mar 2023 Praveen was pivotal for the CRP activity conducted at IQVIA, where he was able to identify multiple issues within the new Database diligently and got it rectified.
- IQVIA IMPACT Award for consistently delivered high-quality work with good productivity. Has always supports to take up the priority assignments and complete them with efficiency and accuracy. He is also managing the all corrections cases and effectively lead the daily DE/QC huddle.
- He additionally supports for all the queries coming from DE/QC Team members. Thank you for your support.
Timeline
Leadership Skills - Indian Institute of Management Ahmedabad https://coursera.org/verif y/DADERGGQEDZ8
05-2023
“Powerful Prioritization with the 80/20 Rule” by Pete Mockaitis
07-2022
“Managing Skills for Remote Leaders” by Madecraft and Mary Jean Vignone, Ph.D. Organizational Development! - Project Management Institute
07-2022
“Excel: PivotTables for Beginners” by Dave Ludwig! - Project Management Institute
06-2022
Safety Operations Workflow Lead
IQVIA
01.2021 - Current
Data Analyst Trainer
Cognizant Technology Solutions
12.2013 - 12.2020
Senior Drug Safety Associate
Tata Consultancy Services
05.2012 - 12.2013
Clinical Research Coordinator
Shrikrishna Hrudayalaya & Critical Care Centre
05.2011 - 05.2012
Master of Pharmacy - Pharmacology
Institute of Pharmaceutical Education And Research
06.2009 - 06.2011
Lecturer
Anurag College Of Pharmacy, Warthi, Bhandara
04.2007 - 06.2009
Bachelor of Pharmacy - Pharmacy
Smt. Kishoritai Bhoyar College of Pharmacy
06.2002 - 06.2007
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