Location- Bangalore, Pune, Mumbai, Delhi/Noida & Hyderabad (Hybrid)

Role Summary
The Vigilance Agreements Team Specialist is responsible for the end-to-end management, negotiation, and execution of Pharmacovigilance and Materiovigilance Agreements (SDEAs and MVAs). This role functions as a subject matter expert, ensuring agreements are aligned with regulatory requirements, company SOPs, and associated commercial arrangements. The position requires solid judgment, stakeholder management, and ownership of the full agreement lifecycle.

Key Responsibilities
Lead end-to-end development, negotiation, and execution of SDEAs and MVAs with partners globally
Serve as the primary point of contact for vigilance agreement discussions with internal and external stakeholders (Legal, RA, Quality, Commercial, Partners)
Ensure agreements are accurate, complete, and aligned with associated commercial agreements and product scope
Interpret partner roles (e.g., MAH, distributor, manufacturer) and determine the appropriate agreement structure and template
Drive timely review cycles,



including amendments, renewals, and lifecycle management
Ensure all agreements comply with global regulatory requirements, internal SOPs, and audit expectations
Identify and resolve gaps, inconsistencies, or risks in agreement language or product coverage
Maintain audit-ready documentation, including trackers, supporting records, and note-to-file justifications where needed
Provide guidance and expertise to cross-functional teams on vigilance agreement requirements and responsibilities
Support inspections and audits by ensuring documentation is complete, consistent, and defensible

Qualifications & Experience
Significant experience in Pharmacovigilance and/or Materiovigilance agreements (SDEA/MVA)
Proven track record of independently negotiating and managing agreements end-to-end
Strong understanding of global PV/MV regulatory requirements and industry practices
Excellent communication Experience working w

📌 Vigilance Agreement Specialist (Bengaluru)
🏢 Indegene
📍 Bengaluru