Vigilance Agreement Specialist

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 strong 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 with cross-functional and other stakeholders
• Ability to assess complex scenarios and apply appropriate agreement strategy and structure
• Detail-oriented with a strong focus on compliance, audit readiness, and data consistency