Role:
We are looking for a qualified and experienced Medical Reviewer – ICSR to join our Pharmacovigilance team. The ideal candidate will bring strong medical expertise along with hands-on experience in safety case evaluation and regulatory compliance.
Key Responsibilities
Perform medical review of Individual Case Safety Reports (ICSRs)
Conduct medical triage of adverse event reports for completeness, consistency, and clinical relevance
Review and validate medical literature for safety signals and case-related information
Provide medical input for follow-ups in clinical trial and post-marketing cases
Support compliance monitoring and contribute to CAPA activities
Participate in pharmacovigilance audits and regulatory inspections
Act as a Subject Matter Expert (SME) for safety evaluations and health hazard assessments
Collaborate with cross-functional teams to ensure timely case processing and compliance




Interact with healthcare professionals and regulatory authorities for medical queries
Train and mentor team members on pharmacology and PV processes
Ensure documentation aligns with SOPs, regulatory guidelines, and client requirements
Experience & Qualifications
MBBS (mandatory)
Minimum 2+ years of Pharmacovigilance experience (Clinical Safety / Post-Marketing)
Strong knowledge of FDA, ICH, and global safety reporting regulations
Experience with pharmacovigilance safety databases and MS Office tools
Key Skills
Robust medical judgment and analytical thinking
Excellent communication and stakeholder management skills
Ability to manage multiple priorities under strict timelines
Knowledge of signal detection and risk assessment
Project management and leadership capabilities

📌 Medical Reviewer (Hyderabad)
🏢 Synapmed
📍 Hyderabad