Looking to advance your career in pharmacovigilance (PV) with a strong focus on regulatory documentation and compliance? Arcolab is hiring an experienced XEVMPD/PSMF Associate in Bengaluru. This is a high-impact role ideal for professionals skilled in PSMF authoring, XEVMPD submissions, aggregate report writing, and ICSR data management.
This opportunity is particularly suited for candidates with 4โ8 years of pharmacovigilance experience who want to work on global regulatory frameworks including EMA and MHRA compliance systems.
Job Overview
Arcolab is seeking a detail-oriented Pharmacovigilance Specialist responsible for maintaining critical PV documentation and ensuring regulatory compliance. The role emphasizes PSMF lifecycle management, XEVMPD filings, PSUR/PADER preparation, and ICSR handling.
Key Responsibilities
1. PSMF Authoring & Maintenance
- Develop, review, and maintain the Pharmacovigilance System Master File (PSMF)
- Ensure alignment with global PV systems and regulatory requirements
- Coordinate with cross-functional teams for accurate data collection
- Keep PSMF updated per evolving compliance guidelines
2. XEVMPD Filings
- Manage timely and accurate XEVMPD submissions
- Ensure medicinal product data accuracy in EudraVigilance
- Track regulatory updates and implement changes accordingly
3. Aggregate Report Writing
- Prepare and review PSURs (Periodic Safety Update Reports)
- Develop PADERs (Periodic Adverse Drug Experience Reports)
- Perform safety data analysis and support signal detection
4. ICSR Data Management
- Download and manage ICSRs from EMA and MHRA databases
- Conduct initial data quality checks for completeness and consistency
- Coordinate with case processing teams for further handling
Required Qualifications
- Bachelorโs or Masterโs degree in Pharmacy, Life Sciences, or related field
- 4โ8 years of pharmacovigilance experience
- Hands-on expertise in:
- PSMF authoring and maintenance
- XEVMPD filings
- Aggregate report writing (PSUR, PADER)
- ICSR handling and regulatory databases
- Strong understanding of EMA and MHRA guidelines
- Excellent analytical, documentation, and communication skills
Preferred Skills
- Experience in global pharmacovigilance systems
- Familiarity with signal detection and risk management
- Ability to work in cross-functional and regulatory-driven environments
Salary & Benefits
- Estimated Salary: โน8,00,000 โ โน15,00,000 per annum
- Opportunity to work on global PV compliance frameworks
- Exposure to EMA, MHRA, and international safety databases
- Career growth in drug safety and regulatory affairs
How to Apply
๐ง Send your updated CV to:ย dev.kiran@arcolab.com
