Medical Reviewer – Pharmacovigilance (5+ yrs experience)

About the role

ProductLife Group is seeking an experienced Medical Reviewer to support both clinical‑phase and post‑marketing pharmacovigilance activities. You will work closely with study sites, client medical teams, and internal clinical staff to ensure safety data are accurately assessed and reported.

Key responsibilities

• Review adverse events reported by study sites, assess severity, and recommend actions such as dose adjustments or trial discontinuation.
• Determine SUSAR reportability and perform clinical data interpretation to ensure protocol compliance.
• Draft monthly safety reports and present findings to clients as required.
• Develop and update training materials in line with GCP and GVP guidelines.
• Maintain medical safety platform documentation, SOPs, and manuals.
• Conduct medical review of Individual Case Safety Reports (ICSRs) including spontaneous and literature cases.
• Support causality assessment, benefit‑risk evaluation, and provide feedback through workshops.
• Participate in audits, inspections, and client communications.

Required profile

• MBBS or MD degree.
• Minimum 5 years of pharmacovigilance experience in a service provider or pharmaceutical company.
• Proven experience with safety databases and client communication.
• Strong understanding of GVP, GCP, FDA and other regulatory requirements.
• Excellent written and verbal communication, analytical mindset, and high emotional intelligence.

Required skills

• Proficiency with Microsoft Office suite.
• Working knowledge of Electronic Data Capture (EDC) systems.
• Experience using safety databases for adverse event reporting.