Brief Description of Duties:
This position is independently responsible to
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Medical Review of aggregate reports (PBRER/DSUR/PADER) and related signal
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management activities, screening scientific literature for the purpose of periodic submission as per the Regulations and SOPs.
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Contribute Medical Assessment for Aggregate Reports and HA responses for safety-related topics.
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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.
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Contribute to content and participate in safety governance meetings and other external meetings as applicable (e.g., DMC, Adjudication Committee)
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Active and regular utilization of data review, reporting, and visualization tools and systems to support scientific activity
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Review, manage contribution of development of safety sections of regulatory documents and processes
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Assume RMP authoring ownership
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Collaboration with Safety Scientist, Medical Affairs and Regulatory counterparts
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on implementation and risk minimization measures
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Provide medical and PV oversight and input to Protocols, Investigator brochures,
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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
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Maintain awareness of changes to/new regulations affecting PVG activities.
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Train and mentor new employees in aggregate reports writing and relevant
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pharmacovigilance activities (if required)
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To carry out necessary administrative duties required for the job.
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Other duties as assigned by management
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Builds and maintains good relationships across functional units and company
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affiliates.
