PV XEVMPD/PSMF Associate At Arcolab

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 4–8 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

Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field

4–8 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: ₹8,00,000 – ₹15,00,000 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

📧 Send your updated CV to: dev.kiran@arcolab.com