Medical Reviewer

• Analyze, review, and interpret non-clinical and clinical safety data
• Perform medical review of ICSRs and other drug safety information from clinical trials, spontaneous and solicited reports, aggregate reports, and literature reports
• Provide technical and medical expertise in ICSR causality assessment and assess quality within the ICSR process
• Identify process improvement opportunities and drive changes
• Contribute to aggregate safety reports, including development safety update reports and periodic benefit-risk evaluation reports
• Provide medical input on new and existing safety documents to ensure regulatory compliance
• Contribute to Standard Operating Procedures, Working Instructions, and guidance documents
• Contribute to safety and pharmacovigilance training programs
• Provide safety training at investigator meetings
• Collaborate with Regulatory Affairs on reporting pharmacovigilance and drug safety information to regulatory agencies and prescriber communities
• Serve as a subject matter expert for drug safety and pharmacovigilance service vendors
• Train and mentor Pharmacovigilance Physicians and Specialists
• Ensure compliance with global PV regulations and guidelines, including CIOMS, FDA, PMDA, EMA, and ICH
• Maintain medical knowledge and current knowledge of drug safety, pharmacovigilance regulations, safety surveillance, and risk-management practices
• Collaborate with Sitero safety teams, CROs, and partners on benefit-risk assessment and safety communication

Medical Reviewer jobs in India

Medical Reviewer – ICSR