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Looking to advance your career in pharmacovigilance (PV) with a focus on PSMF authoring, XEVMPD filings, and aggregate report writing? Arcolab is hiring experienced professionals for the role of XEVMPD/PSMF Associate in Bengaluru.
This opportunity is ideal for candidates with 4โ8 years of experience in pharmacovigilance, especially those skilled in PSUR, PADER, ICSR management, and global regulatory compliance (EMA, MHRA).
If you’re aiming for a high-impact PV role in regulatory safety documentation, this is a strong career move.
Job Details
- Job Title: XEVMPD / PSMF Associate
- Company: Arcolab
- Location: Bengaluru, India
- Experience: 4 โ 8 years
- Salary: โน8 โ โน16 LPA (estimated based on industry standards)
- Employment Type: Full-Time
Key Responsibilities
1. PSMF Authoring & Maintenance
- Develop, review, and maintain Pharmacovigilance System Master File (PSMF)
- Ensure alignment with global PV regulations and company systems
- Coordinate cross-functional teams for accurate documentation
- Maintain compliance with EMA pharmacovigilance requirements
2. XEVMPD Filings
- Perform accurate XEVMPD submissions (EudraVigilance Medicinal Product Dictionary)
- Ensure medicinal product data accuracy and consistency
- Track and implement updates as per EU regulatory guidelines
3. Aggregate Report Writing
- Prepare and review:
- PSUR (Periodic Safety Update Reports)
- PADER (Periodic Adverse Drug Experience Reports)
- Perform signal detection and safety data analysis
- Present risk-benefit evaluation in structured reports
4. ICSR Data Management
- Download and manage ICSRs from:
- EMA (European Medicines Agency)
- MHRA (UK Medicines Authority)
- Ensure completeness and consistency of safety data
- Coordinate with case processing teams
Required Qualifications
- Education: B.Pharm / M.Pharm / Life Sciences
- Experience: 4โ8 years in Pharmacovigilance
- Core Skills:
- PSMF authoring & maintenance
- XEVMPD submissions
- PSUR / PADER writing
- ICSR handling (EMA, MHRA)
- Signal detection & risk assessment
- Strong understanding of:
- ICH Guidelines
- EU Pharmacovigilance regulations
Preferred Skills
- Experience with EudraVigilance systems
- Strong documentation & analytical skills
- Ability to work with cross-functional global teams
- Regulatory inspection readiness experience
Benefits of Joining Arcolab
- Work in advanced pharmacovigilance systems (EU-focused)
- Exposure to global regulatory frameworks (EMA, MHRA)
- Opportunity to handle high-level PV documentation (PSMF, PSUR)
- Career growth into PV strategy, aggregate reporting, and risk management
How to Apply
๐ง Send your updated CV to: dev.kiran@arcolab.com
๐ Subject Line: Application for XEVMPD/PSMF Associate โ Bengaluru
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