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Pharmacovigilance Agreements Specialist

Tcs
TCS
3-7 years
preferred by company
Mumbai, India
1 May 13, 2026
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes

Job Title: Pharmacovigilance Agreements Specialist

Location: Mumbai, India
Work Mode: Onsite / Hybrid (as applicable)
Employment Type: Full-Time
Experience Required: 3–7 Years
Industry: Pharmacovigilance / Drug Safety / Life Sciences / Pharmaceutical Operations

Job Overview

We are hiring a Pharmacovigilance Agreements Specialist to support global pharmacovigilance contractual operations, pharmacovigilance agreement (PVA) lifecycle management, compliance monitoring, and stakeholder coordination.

This role is ideal for professionals with expertise in pharmacovigilance operations, PV agreements, drug safety compliance, global pharmacovigilance regulations, contractual governance, and documentation management.

The ideal candidate will manage PV agreement drafting, review, compliance tracking, stakeholder communication, and repository governance while ensuring adherence to company and regulatory pharmacovigilance requirements.


Key Responsibilities

Pharmacovigilance Agreement (PVA) Management

  • Draft new Pharmacovigilance Agreements (PVAs) and revisions in line with organizational requirements.
  • Ensure consistency, accuracy, and completeness of PV contractual documentation.
  • Manage end-to-end lifecycle of pharmacovigilance agreements.

Agreement scope includes:

  • Global PV Agreements
  • Local PV Agreements
  • Safety contractual governance documentation

PVA Review & Quality Assurance

  • Review new and revised PV agreements to ensure:
    • Quality compliance
    • Regulatory alignment
    • Contractual consistency
    • Internal standard adherence
  • Perform quality checks before agreement finalization.

Stakeholder Comment Resolution

  • Address internal company comments on PV agreements.
  • Coordinate and resolve collaborating partner / client comments.
  • Support negotiation and clarification of agreement terms where applicable.

Mailbox & Communication Management

  • Manage dedicated PVA operational mailbox.
  • Respond to stakeholder queries related to:
    • Agreement status
    • Documentation
    • Updates
    • Operational escalations
  • Maintain effective communication across stakeholders.

Stakeholder Notifications

  • Announce newly approved or revised PV agreements to relevant stakeholders.
  • Ensure timely communication of agreement updates across affected teams.

Stakeholders may include:

  • Drug safety teams
  • Regulatory teams
  • Quality teams
  • Partner organizations
  • Business stakeholders

PVA Tracker Management

  • Maintain centralized tracker for all active global pharmacovigilance agreements.
  • Track:
    • Agreement status
    • Effective dates
    • Renewals
    • Revisions
    • Reconciliations
    • Compliance actions
  • Ensure tracker accuracy and governance.

Compliance Monitoring & Reporting

  • Perform ongoing compliance monitoring for active PV agreements.
  • Assess adherence to contractual pharmacovigilance obligations.
  • Prepare:
    • Compliance dashboards
    • Monitoring reports
    • Agreement governance updates

Support operational risk visibility.


Documentation & Repository Management

  • Upload and maintain PV agreements and related documentation in company repositories.
  • Ensure document version control, accessibility, and audit readiness.
  • Maintain structured documentation governance.

Project Coordination Support

  • Assist project managers / designated leads with:
    • Project trackers
    • Documentation updates
    • Agreement governance activities
    • Operational support

Team Collaboration

  • Participate in operational team meetings.
  • Provide updates on:
    • PVA progress
    • Compliance status
    • Risks
    • Operational issues
    • Agreement bottlenecks

Required Qualifications

Education

  • Bachelor’s degree in:
    • Pharmacy (B.Pharm)
    • Life Sciences (B.Sc)
    • Related healthcare/scientific disciplines