Website:
synapmed.com
Job details:
Role:
We are looking for a qualified and experienced Medical Reviewer – ICSR & Signal Detection 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
- Strong 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
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