Manish Kadam
Senior Pharmacovigilance Manager
Pune,MH
Summary
Senior Pharmacovigilance Manager with 15+ years of expertise in global drug safety, and 2 years of specialized experience in medical device vigilance and complaint management. Proven track record of leading 100+ FTE global teams, delivering high-quality ICSR management, and regulatory submissions. Skilled in audit and inspection readiness, CAPA development, and regulatory compliance with ICH-GVP, EU MDR, FDA 21 CFR Part 803, and ISO 13485. Adept at implementing and validating PV systems (ARISg, LSMV), driving operational efficiencies, and building inspection-ready, high-performing teams. Recognized for fostering cross-functional collaboration.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Senior Pharmacovigilance Manager
Tata consultancy services
07.2021 - Current
- Managed 100 FTE team members to execute global ICSR and medical device vigilance activities.
- Oversaw device complaint handling, MDR reporting, under EU MDR, and FDA MDR.
- Involved in testing and validating PV systems (ARISg, LSMV) to enhance device safety workflows.
- Led various ICSR teams, including Literature, Deletion, SAE reconciliation, Intake, Quality review, Data correction, etc.
- Maintained audit readiness and led CAPA programs for successful inspections.
- Drove resource planning, recruitment, and budget management for multiple projects.
- Fostered customer-centric culture within teams to strengthen collaboration and partnerships.
- Developed high-performing teams through strategic influence and motivation techniques.
- Executed critical projects with high case volumes by implementing innovative process improvements.
Subject Matter Expert
Tata consultancy services
01.2020 - 06.2021
- Authored training materials to enhance compliance understanding across teams.
- Oversaw ICSR follow-up processes to ensure timely resolution of issues.
- Designed compliance metrics to assess alignment with regulatory standards.
- Led process improvement initiatives, integrating regulatory requirements with operational delivery.
Assistant Manager – PV Operations
Tata consultancy services
05.2015 - 12.2019
- Directed daily case processing, quality control, and regulatory submissions to ensure compliance.
- Managed team performance metrics, focusing on service level agreement adherence and inspection readiness.
- Held overall accountability for day-to-day case processing activities, including productivity and compliance monitoring.
- Ensured team members were audit- and inspection-ready, participating in audits as required.
- Enhanced employee morale by recognizing outstanding achievements and celebrating successes.
- Recruited, interviewed, and hired employees, implementing a mentoring program for positive feedback.
- Evaluated employee performance, providing constructive feedback to enhance skillsets.
- Established performance goals and advised on methods to reach milestones.
Technical Trainer and Mentor (PV)
Tata Consultancy Services
03.2012 - 04.2015
- Reduced new hire ramp-up time through a structured mentoring program, pairing newcomers with mentors in association with the client.
- Enhanced technical skills via comprehensive training modules and hands-on workshops.
- Streamlined onboarding by developing an easy-to-follow technical orientation program.
- Delivered train-the-trainer sessions empowering internal subject matter experts.
- Maintained detailed records of employee progress to enable manager tracking.
- Evaluated training effectiveness with feedback surveys, adjusting content as needed.
- Conducted thorough needs assessments to identify improvements in training materials and methods.
Drug Safety Associate
Tata Consultancy Services
03.2011 - 02.2012
- Validated ICSRs through comprehensive assessments and duplicate case identifications.
- Processed valid ICSRs into ARISg adhering to established SOPs and data handling guidelines.
- Conducted labeling and causality assessments for identified SUSARs to ensure compliance.
- Performed quality control checks on drug safety reports, ensuring accuracy before regulatory submission.
- Resolved discrepancies during adverse event data entry to uphold data integrity.
- Supported regulatory inspections by demonstrating extensive knowledge of compliance requirements.
- Identified opportunities for process improvements within drug safety department, enhancing productivity.
- Reviewed ancillary documentation to facilitate accurate electronic capture of necessary information.
Education
M. Pharm. - Pharmaceutical Sciences
Manipal College of Pharmacy
Manipal University, Karnataka06.2008
B Pharm - Pharmaceutical Sciences
GSPS Institute Of Pharmacy
SGB Amravati University, Amravati06.2005
Skills
- Global PV operations (clinical and post-marketing)
- Medical device vigilance and Device complaint management
- ICSR case processing, QC, and submissions (EMA, FDA, MHRA, PMDA)
- Audit/inspection readiness and CAPA execution
- PV systems: ARISg, LSMV
- Client relationship management
- Leadership of large teams
- Change management
- Cross-functional team management
- Recruiting and interviewing
- Coaching and mentoring
- Performance evaluations
Accomplishments
- Managed a successful transition and migration of a high-volume medical device project from another vendor to TCS for the client
- Managing a high-volume medical device complaint management project from the client to TCS.
- Awarded the High Potential Resource (HIPOT) four times at TCS
- Received multiple monthly, quarterly, and yearly awards for excellent performance
- Actively involved in transitioning and establishing a new ICSR processing site in Cincinnati, USA, and Pune
Certification
- Certified Agile Coach
- Certified Scrum master (PSM1)
Timeline
Senior Pharmacovigilance Manager
Tata consultancy services
07.2021 - Current
Subject Matter Expert
Tata consultancy services
01.2020 - 06.2021
Assistant Manager – PV Operations
Tata consultancy services
05.2015 - 12.2019
Technical Trainer and Mentor (PV)
Tata Consultancy Services
03.2012 - 04.2015
Drug Safety Associate
Tata Consultancy Services
03.2011 - 02.2012
M. Pharm. - Pharmaceutical Sciences
Manipal College of Pharmacy
B Pharm - Pharmaceutical Sciences
GSPS Institute Of Pharmacy
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