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Job Post Details

Global Medical Safety Physician - job post

Soterius
Remote
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Job details

Job type

  • Full-time

Full job description

Brief Description of Duties:

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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