Senior PV Physician

  • Full-time
  • Department: PV Medical Group

Job Description

For the Client:

•          To review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports occurring in clinical trials for medical/causality assessment. The review includes coding, seriousness assessment, Company causality and comment, listedness/expectedness and follow-up questions.

•          To act as a Qualified Person for Pharmacovigilance or support the Qualified Person for Pharmacovigilance (if not medically qualified) in the medical understanding and evaluation of any safety issues

•          To review and provide input in Periodic Safety Update Reports, Development Safety Update Reports, literature screening search strategy

•          To review articles to determine if they contain ICSRs/SAEs related to the relevant Medicinal Product or other safety related findings

•          To cooperate in the preparation of and provide input in Risk Management Plans

•          Supporting the preparation of responses to regulatory authority requests

 

Signalling

•          Reviewing line listings

•          Participating in signal detection activities including meetings, writing signal detection reports if applicable if required, and providing consultation to clients on aspects related to benefit/risk assessment and risk minimisation

•          Evaluating and categorizing possible signals and proposing a course of action

•          Supporting preparation and review of benefit-risk reports

Additional Information

  • The PV Physician should be medically qualified as a physician
  • 2+ years of work experience in pharmacovigilance
  • Ability to review different aggregate report types including PBRERs and DSURs
  • Expertise in signal detection activities is essential
  • Excellent interpersonal skills
  • Ability to plan, organise, prioritise and execute multiple tasks
  • Ability to work effectively cross-culturally and cross-functionally and value the importance of teamwork
  • Communication skills  
  • Presentation skills
  • English - advanced (spoken, written)
  • Advanced literacy (MS Office)
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