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
- Assume RMP authoring ownership
- 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)
- 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
- affiliates.
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