Indegene is hiring experienced professionals for the position of Vigilance Agreement Specialist. This opportunity is suitable for pharmacovigilance professionals with strong expertise in Safety Data Exchange Agreements (SDEA), Materiovigilance Agreements (MVA), global vigilance agreements, regulatory compliance, and agreement lifecycle management.
The Vigilance Agreement Specialist will manage the end-to-end development, negotiation, execution, amendment, renewal, and maintenance of pharmacovigilance and materiovigilance agreements with global partners. Professionals with experience working across Pharmacovigilance, Regulatory Affairs, Quality, Legal, Commercial, and partner organizations may find this role particularly relevant.
Indegene Vigilance Agreement Specialist Job Overview
| Particular | Details |
|---|---|
| Company | Indegene |
| Job Title | Vigilance Agreement Specialist |
| Function | Pharmacovigilance / Materiovigilance |
| Employment Type | Full-time |
| Work Mode | Hybrid |
| Locations | Bengaluru, Pune, Mumbai, Delhi/Noida & Hyderabad |
| Key Expertise | SDEA, MVA, Vigilance Agreements |
| Experience | Significant relevant PV/MV agreement experience |
| Application Mode | Online / Profile Submission |
About the Role
The Vigilance Agreements Team Specialist is responsible for managing Pharmacovigilance and Materiovigilance Agreements throughout their lifecycle.
The specialist acts as a subject matter expert for SDEA and MVA management, ensuring that vigilance agreements comply with applicable global regulations, internal standard operating procedures, commercial arrangements, product responsibilities, and audit requirements.
The position requires independent decision-making, agreement negotiation capabilities, strong stakeholder management, and detailed knowledge of pharmacovigilance compliance.
Key Responsibilities
- Lead the end-to-end development, review, negotiation, and execution of Safety Data Exchange Agreements (SDEAs) and Materiovigilance Agreements (MVAs).
- Manage vigilance agreements with partners across different global markets.
- Serve as a primary point of contact for agreement-related discussions involving Legal, Regulatory Affairs, Quality, Commercial teams, and external partners.
- Ensure agreements accurately reflect product scope, responsibilities, and associated commercial arrangements.
- Understand partner roles such as Marketing Authorization Holder (MAH), distributor, and manufacturer to determine the appropriate vigilance agreement structure.
- Select and apply appropriate SDEA/MVA templates according to the business relationship.
- Coordinate agreement reviews, amendments, renewals, and other lifecycle management activities.
- Ensure vigilance agreements comply with global PV/MV regulations, internal SOPs, and audit requirements.
- Identify inconsistencies, compliance gaps, missing information, and potential risks in agreement language.
- Maintain accurate and audit-ready trackers, supporting records, agreement documentation, and note-to-file justifications.
- Provide subject matter guidance to cross-functional teams regarding vigilance agreement responsibilities.
- Support regulatory inspections and internal/external audits by maintaining complete and defensible documentation.
Qualifications & Eligibility
The job posting does not specify a mandatory academic degree. Candidates with relevant Pharmacovigilance or Materiovigilance experience and strong SDEA/MVA agreement expertise are the primary target applicants.
Relevant educational backgrounds may include B.Pharm, M.Pharm, Pharm.D, B.Sc/M.Sc in Life Sciences, Biotechnology, Microbiology, Biochemistry, Clinical Research, Nursing, or other relevant healthcare/life-science qualifications, provided the candidate meets the required professional experience and skills.
Key Skills Required
Candidates should have strong knowledge or practical experience in:
- Safety Data Exchange Agreements (SDEA)
- Materiovigilance Agreements (MVA)
- Global Vigilance Agreements
- Pharmacovigilance regulations
- Materiovigilance requirements
- Agreement drafting and negotiation
- Agreement lifecycle management
- Regulatory compliance
- Audit and inspection readiness
- Documentation management
- Stakeholder management
- Risk and gap assessment
- Cross-functional collaboration
- PV/MV SOPs and industry practices
Experience Requirements
Indegene is seeking experienced professionals rather than entry-level candidates for this opening.
Applicants should have significant experience in Pharmacovigilance and/or Materiovigilance agreements, with demonstrated ability to independently negotiate and manage SDEA, MVA, or other vigilance agreements from initiation through execution and lifecycle maintenance.
Candidates should also be comfortable working with global stakeholders and cross-functional functions such as Regulatory Affairs, Quality, Legal, Commercial, and external business partners.
Benefits of This Opportunity
While specific compensation and employee benefits were not disclosed in the provided job posting, this opportunity offers professionals exposure to:
- Global pharmacovigilance and materiovigilance operations
- End-to-end SDEA/MVA management
- Cross-functional stakeholder collaboration
- Global regulatory compliance activities
- Audit and inspection readiness
- Vigilance agreement strategy and lifecycle management
- Hybrid working arrangements
Candidates should verify compensation, insurance, leave, incentives, and other employment benefits directly with Indegene during the recruitment process.
How to Apply
📩 Interested candidates can share your profile on lavanya.y@indegene.com
