Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven.  We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Must Have

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

Good to have

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.