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 c

📌 Medical Reviewer (Telangana)
🏢 Synapmed
📍 Telangana