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Pv Manager – Veeva (Pharmacovigilance Manager)

Tcs
TCS
5-12 years
preferred by company
Mumbai, India
1 May 13, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L.

Job Title: PV Manager – Veeva (Pharmacovigilance Manager)

Location: Mumbai, India
Employment Type: Full-Time
Role Level: Lead
Industry: Pharmacovigilance / Drug Safety / Life Sciences / Pharmaceutical Operations / Business Process Services

Job Overview

We are looking for an experienced PV Manager – Veeva to lead pharmacovigilance operations, Veeva Vault Safety administration, drug safety compliance, safety reporting, and pharmacovigilance system optimization.

This role is ideal for professionals with deep expertise in pharmacovigilance, drug safety operations, Veeva Vault Safety, regulatory compliance, aggregate reporting, safety data management, and global PV systems.

The ideal candidate will oversee Veeva safety platform operations, configure pharmacovigilance workflows, ensure global regulatory compliance, and collaborate across clinical, regulatory, quality, and IT teams.


Key Responsibilities

Veeva Vault Safety Administration

  • Manage end-to-end operation, maintenance, and governance of the Veeva Vault Safety platform.
  • Configure and customize Veeva Vault Safety to align with:
    • Organizational business needs
    • Pharmacovigilance workflows
    • Regulatory compliance requirements
    • Drug safety operational processes
  • Ensure system performance, reliability, and process efficiency.

Pharmacovigilance Operations Management

  • Lead operational workflows for:
    • Adverse Event (AE) reporting
    • Serious Adverse Event (SAE) processing
    • Safety case workflows
    • Risk management
    • Safety signal monitoring support
    • Safety data evaluation
  • Optimize pharmacovigilance execution across the safety lifecycle.

Regulatory Compliance & Safety Governance

Ensure compliance with global pharmacovigilance regulations including:

  • FDA
  • EMA
  • ICH guidelines
  • Global drug safety reporting requirements

Responsibilities include:

  • Regulatory compliance oversight
  • Audit readiness support
  • Governance monitoring
  • Safety reporting compliance

Safety Reporting & Regulatory Documentation

  • Prepare and support submission of:
    • Periodic safety reports
    • Aggregate safety reports
    • Regulatory safety documentation
    • Compliance reporting deliverables
  • Ensure regulatory submissions are accurate and timely.

Safety Data Management & Analysis

  • Oversee collection, validation, processing, and analysis of safety data.
  • Ensure:
    • Data integrity
    • Accuracy
    • Confidentiality
    • Compliance with internal and regulatory standards
  • Support actionable pharmacovigilance insights through safety analytics.

Reporting & Dashboard Generation

  • Develop and generate safety reports for:
    • Internal leadership
    • Regulatory stakeholders
    • Operational teams
    • External reporting requirements
  • Support trend analysis and decision-making.

Cross-Functional Collaboration

Collaborate with:

  • Clinical teams
  • Regulatory Affairs
  • Drug Safety teams
  • IT teams
  • Quality teams
  • Program stakeholders

Responsibilities include:

  • Workflow optimization
  • System enhancements
  • Risk discussions
  • Safety process alignment
  • Operational issue resolution

Risk Management Support

  • Participate in cross-functional discussions related to:
    • Safety trends
    • Potential safety risks
    • Process governance
    • Signal evaluation support
  • Strengthen proactive pharmacovigilance oversight.

Continuous Improvement

  • Identify opportunities for improvement in:
    • PV workflows
    • Veeva system utilization
    • Safety reporting efficiency
    • Compliance processes
    • Data governance
  • Drive process transformation initiatives.

Regulatory Change Management

  • Monitor regulatory changes impacting pharmacovigilance systems.
  • Implement required Veeva workflow/process updates.
  • Maintain alignment with evolving compliance expectations.

Required Qualifications

Education

Bachelor’s or Master’s degree in:

  • Pharmacy
  • Nursing
  • Life Sciences
  • Related scientific/healthcare disciplines

Preferred: Master of Pharmacy (M.Pharm)