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Pv Veeva Manager (Pharmacovigilance Veeva Vault Safety Lead)

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: Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Scien, Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Pro, Collaboration, Communication Skills, gmp, GMP Guidelines, Operational Excellence, Problem Solving Skills, Quality Agreements, Quality Compliance, Quality Management, Quality Standards, Regulatory Requ, Communication Skills, Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Man

Job Title: PV Veeva Manager (Pharmacovigilance Veeva Vault Safety Lead)

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

Job Overview

We are hiring an experienced PV Veeva Manager to lead pharmacovigilance operations, drug safety system management, regulatory compliance, and safety data oversight using Veeva Vault Safety.

This role is ideal for professionals with strong expertise in pharmacovigilance operations, adverse event reporting, Veeva Vault Safety configuration, safety data analysis, regulatory submissions, and global drug safety compliance.

The ideal candidate will manage Veeva safety platforms, ensure compliance with global PV regulations, optimize pharmacovigilance workflows, and collaborate with clinical, regulatory, and IT stakeholders.


Key Responsibilities

Veeva Vault Safety System Management

  • Oversee end-to-end operation, administration, and maintenance of the Veeva Vault Safety platform.
  • Configure and customize the system based on:
    • Business requirements
    • Pharmacovigilance workflows
    • Regulatory compliance needs
    • Organizational process requirements
  • Ensure optimal system performance, reliability, and governance.

Pharmacovigilance Operations Management

  • Manage pharmacovigilance workflows including:
    • Adverse Event (AE) reporting
    • Serious Adverse Event (SAE) processing
    • Case intake workflows
    • Safety signal support
    • Risk management processes
    • Safety data review workflows
  • Support operational excellence in drug safety activities.

Regulatory Compliance

  • Ensure compliance with global pharmacovigilance regulations including:
    • FDA
    • EMA
    • ICH guidelines
    • Global PV reporting standards
  • Monitor regulatory changes and implement required updates within safety systems and processes.
  • Maintain audit-ready pharmacovigilance operations.

Regulatory Reporting

  • Support preparation and submission of safety regulatory documentation including:
    • Periodic safety reports
    • Aggregate safety reports
    • Regulatory safety documentation
    • Compliance-related submissions
  • Ensure accuracy, timeliness, and regulatory adherence.

Safety Data Management & Analysis

  • Manage collection, validation, processing, and maintenance of pharmacovigilance safety data.
  • Ensure:
    • Data integrity
    • Accuracy
    • Confidentiality
    • Compliance with data governance standards
  • Analyze safety data trends and support risk evaluation activities.

Reporting & Analytics

  • Develop and generate safety reports for:
    • Internal stakeholders
    • Regulatory teams
    • Business leadership
    • External reporting requirements
  • Support actionable safety insights through reporting analytics.

Cross-Functional Collaboration

Work closely with:

  • Clinical teams
  • Regulatory affairs teams
  • IT teams
  • Drug safety teams
  • Quality/compliance teams

Responsibilities include:

  • Workflow optimization
  • System enhancement
  • Risk discussions
  • Safety trend reviews
  • Process alignment

Process Improvement & Optimization

  • Identify opportunities to improve:
    • Pharmacovigilance workflows
    • Safety system performance
    • Regulatory efficiency
    • Data management practices
  • Drive continuous improvement initiatives in PV operations.

Risk Management Support

  • Support safety risk identification and pharmacovigilance governance activities.
  • Participate in discussions around:
    • Safety trends
    • Signal review support
    • Emerging risks
    • Process compliance

Required Qualifications

Education

  • Bachelor’s or Master’s degree in:
    • Pharmacy
    • Nursing
    • Life Sciences
    • Related healthcare/scientific disciplines

Preferred: Master of Pharmacy (M.Pharm)


Experience Required

  • 5–12 years of experience
  • Strong pharmacovigilance / drug safety background

Mandatory experience in:

  • Veeva Vault Safety
  • Drug safety operations
  • PV workflows
  • Safety data management
  • Regulatory compliance

Preferred:

  • Experience in global pharmacovigilance environments