ProPharma Group is Hiring Drug Safety Specialist

ProPharma Group is Hiring Drug Safety Specialist

12 June, 2022

Hiring for Medical Reviewer Position :

Exp : 1-4yrs

Qualification : MBBS

· Provide expert medical safety analysis for periodic safety aggregate reports (e.g. DSUR, PSUR/PBRER, PADER, bridging reports, Signal reports, Health authority requests/queries and other relevant aggregate reports for pharmaceutical products and biiologics.

· Provide medical safety expert opinion for Signal detection process and risk management activities.

  • Provide Medical review of scientific Literature articles/abstracts along with expert or company comment
  • Must be able to assess and identify safety risks and potential signals in safety report or from designated RSI of suspect product.
  • Must be able to perform accurate labeling assessment wherever required for periodic safety reports.
  • Must be able to handle all medical relevant queries and address medical related issues from health authority queries/Vendor queries related to aggregate reports or Signal detection reports.
  • Must regularly Liase with peer medical reviewers and also with vendor medical reviewers in assessing expert outcome or opinion for all Safety reports.
  • Providing oversight for overall Pharmacovigilance (PV) and medical affairs for relevant medical products.
  • Must be able to take up any additional PV activities as delegated by the reporting manager relevant to functionality of process or project at organization
  • Would be an active part of any vendor related AUDITs, safety committee meetings and be responsible for any medical review relevant activities.
  • Should maintain all medical relevant trackers /Minutes of meetings/training records on a real time basis.

· Provides training to pharmacovigilance associates or newly joined medical reviewers on medical relevant topics, as and when required.

Should be able to conduct medical relevant knowledge sessions to entire team as and when required on medical relevant topics related to underlying indication or medical disorder in discussion.

Apply through this Link

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