Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Timeline
CustomerServiceRepresentative
Manish  Kadam

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, Karnataka
06.2008

B Pharm - Pharmaceutical Sciences

GSPS Institute Of Pharmacy
SGB Amravati University, Amravati
06.2005

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
Manish KadamSenior Pharmacovigilance Manager