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A leading global Research & Development organization is hiring a Safety Documentation Specialist in Mumbai, India. This pharmacovigilance (PV) documentation role focuses on periodic safety reports, Risk Management Plans (RMP), PSMF maintenance, and eCTD document management.
If you have 3+ years of experience in pharmacovigilance document management, DARIUS system handling, and eCTD formatting, this opportunity offers strong exposure to global safety regulations, GPV systems, and audit readiness.
📌 Job Overview
- Role: Safety Documentation Specialist
- Location: Mumbai, India
- Department: Research & Development
- Experience: Minimum 3 Years
- Industry: Pharmacovigilance / Drug Safety / Regulatory
🔬 Key Responsibilities – Safety Documentation Specialist
The Safety Documentation Specialist will:
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- Distribute Medical Safety Documents to internal stakeholders, affiliates, and license partners
- Process, format, and archive periodic safety reports and Risk Management Plans (RMP)
- Perform eCTD formatting and document publishing as per global PV regulations
- Act as GPV Business Administrator for the DARIUS Document Management System
- Manage GPV-specific documents and archive oversight in DARIUS
- Maintain electronic archives, SharePoint drives, and document repositories
- Support PV inspections and audits (back-office support)
- Serve as Deputy PSMF Coordinator
- Maintain and update the Pharmacovigilance System Master File (PSMF)
- Provide PSMF documentation upon regulatory request
This role requires advanced knowledge of pharmacovigilance terminology, global safety reporting requirements, and document lifecycle management.
🎓 Qualifications & Experience
Minimum Education:
- Industrial Business Management Assistant / Documentation Specialist or equivalent qualification
Experience:
- Minimum 3 years of experience in pharmacovigilance documentation or safety reporting
- Strong experience in:
- eCTD formatting and publishing
- Periodic Safety Reports (PSUR, DSUR, PBRER)
- Risk Management Plans (RMP)
- DARIUS Document Management System
- PSMF maintenance
Technical Skills:
- Advanced Microsoft Excel, Word, PowerPoint, Outlook
- SharePoint & e-room technology
- HTML basics preferred
- Document management systems expertise
Core Competencies:
- Strong multitasking and organizational skills
- Detail-oriented approach
- Excellent written and verbal English communication
- Audit and inspection readiness exposure
💼 Why Apply?
- Exposure to global pharmacovigilance systems
- Hands-on experience in PSMF coordination
- Work on eCTD safety submissions
- PV inspection & audit involvement
- Growth in Drug Safety Documentation & Regulatory Compliance
💰 Estimated Salary Range
For Mumbai R&D pharmacovigilance roles:
- ₹8,00,000 – ₹14,00,000 per annum (CTC)
(Based on 3–6 years PV document management experience)
📥 How to Apply
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