Website:
synapmed.com
Job details:
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 and ensure accuracy in both clinical trial and post-marketing cases
· Support compliance monitoring and contribute to CAPA (Corrective and Preventive Actions)
· Actively participate in pharmacovigilance audits and inspections by regulatory authorities
· Serve as a Subject Matter Expert (SME) for safety-related evaluations, including health hazard assessments
· Collaborate with cross-functional teams to ensure timely case processing and regulatory compliance
· Interact with healthcare professionals and regulatory authorities to address medical queries
· Train and mentor team members on pharmacological concepts and PV processes
· Ensure all documentation aligns with applicable SOPs, regulatory guidelines, and client requirements
Experience & Qualifications
· MBBS
· At least 2+ years of Pharmacovigilance experience (Clinical Safety or Post-Marketing)
· Strong knowledge of FDA, ICH, and global safety reporting regulations
· Experience with 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 and meet strict timelines
· Knowledge of signal detection and risk assessment
· Project management and leadership capabilities
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