PV CAPA Manager – Pharmacovigilance
Location: Mumbai, India
Employment Type: Full-Time
Industry: Pharmacovigilance | Drug Safety | Regulatory Compliance
Experience Required: 3–8 Years
Education: Life Sciences Graduate (B.Pharm / M.Pharm / B.Sc / M.Sc)
Apply By: 04 February 2026
Job ID: 385991
Hiring Organization: Tata Consultancy Services (TCS)
Role Overview
Tata Consultancy Services (TCS) is seeking an experienced PV CAPA Manager to support Pharmacovigilance Corrective and Preventive Action (CAPA) activities. This role is critical in ensuring regulatory compliance, audit readiness, and continuous improvement across pharmacovigilance operations. The position requires hands-on expertise in Root Cause Analysis (RCA), SOP management, audits, and inspections, aligned with global regulatory standards.
Key Responsibilities
Issue Detection & CAPA Initiation
Identify CAPA triggers arising from audit findings, deviations, quality issues, and regulatory queries
Initiate RCA activities in line with internal SOPs and regulatory expectations
Root Cause Analysis (RCA)
Lead structured RCA using tools such as Fishbone Analysis, 5-Why methodology, and data-driven approaches
Analyze contributing and systemic factors impacting pharmacovigilance processes
CAPA Planning & Development
Develop comprehensive Corrective and Preventive Action plans with defined ownership, timelines, implementation steps, and effectiveness criteria
Ensure CAPA alignment with EU GVP, ICH guidelines, global regulatory requirements, and internal SOPs
Stakeholder & Cross-Functional Collaboration
Coordinate with internal teams and sub-functions to ensure complete root cause visibility
Facilitate cross-functional CAPA review meetings and implementation planning
Client & Regulatory Interaction
Present RCA findings and CAPA strategies during client review discussions
Address client and regulatory feedback to finalize CAPA documentation and approvals
Implementation Monitoring & Tracking
Track CAPA execution against milestones and timelines
Escalate delays and manage verification activities to ensure timely completion
Effectiveness Checks & CAPA Closure
Conduct effectiveness evaluations to confirm issue resolution and prevention of recurrence
Prepare final CAPA reports, closure documentation, and quality approval packages
Reporting & Continuous Improvement
Generate CAPA metrics and trend reports including aging, recurrence, and compliance status
Identify systemic gaps and recommend process improvements
Audit & Inspection Readiness
Maintain inspection-ready documentation for internal and external audits
Support regulatory inspections by providing evidence of CAPA compliance and effectiveness
Required Qualifications & Experience
Bachelor’s or Master’s degree in Pharmacy or Life Sciences
3–8 years of hands-on experience in Pharmacovigilance CAPA, Quality, or Compliance roles
Strong knowledge of PV regulations, EU GVP, ICH guidelines, and audit processes
Experience handling SOPs, inspections, deviations, and regulatory interactions
Desired Skills & Competencies
Expertise in Medical Regulatory and Pharmacovigilance Quality systems
Strong analytical and problem-solving capabilities
Excellent documentation and stakeholder communication skills
Ability to manage multiple CAPAs in a regulated environment
High attention to detail and compliance-focused mindset
Why Join TCS
Work with one of the world’s leading IT and life sciences service organizations
Exposure to global pharmacovigilance quality and compliance operations
Opportunity to work on high-impact regulatory and audit programs
Strong learning, growth, and career progression environment
Equal Opportunity Statement
TCS is an equal opportunity employer and is committed to fostering an inclusive workplace. Employment decisions are based on business needs, merit, and qualifications, without discrimination of any kind.
Apply via ThePharmaDaily.com
Discover verified global roles in Pharmacovigilance, Drug Safety, CAPA Management, and Regulatory Compliance. Advance your PV career with trusted opportunities from leading organizations.
Apply before 04 February 2026 to join TCS as a PV CAPA Manager in Mumbai.
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