Global Medical Safety Physician

This position is independently responsible to

• Medical Review of aggregate reports (PBRER/DSUR/PADER) and related signal management activities, screening scientific literature for the purpose of periodic submission as per the Regulations and SOPs.
• Contribute Medical Assessment for Aggregate Reports and HA responses for safety-related topics.
• Accountable for product Signalling data review, analysis and delivery in close collaboration with Product Leader. Ensure timely review, approval and communication of findings via governance fora.
• Contribute to content and participate in safety governance meetings and other external meetings as applicable (e.g., DMC, Adjudication Committee)
• Active and regular utilization of data review, reporting, and visualization tools and systems to support scientific activity
• Review, manage contribution of development of safety sections of regulatory documents and processes
• Collaboration with Safety Scientist, Medical Affairs and Regulatory counterparts on implementation and risk minimization measures
• Provide medical and PV oversight and input to Protocols, Investigator brochures, Safety summaries, Clinical study reports, Regulatory reports (periodic, ad hoc) and Generation/review of SOPs and WIs and execution of client and company SOPs
• Ensure compliance with project guidelines
• Maintain awareness of changes to/new regulations affecting PVG activities.
• Train and mentor new employees in aggregate reports writing and relevant pharmacovigilance activities (if required)
• To carry out necessary administrative duties required for the job.
• Other duties as assigned by management
• Builds and maintains good relationships across functional units and company