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Pharmacovigilance Operations Manager (subunit) - India  

Navitas Life Sciences (company)

Posted on : 22 December 2017

Project Description

Category: Manager
Location: Bangalore
Job Type:
Full Time
Education: Graduation / Post Graduation in Medical

Job Description:

  • Management of local pharmacovigilance unit, including operational and compliance aspects, personnel development/training needs, processes and systems of the PV subunit.
  • Participation in and consultation on preparation and presentation of proposals
  • Management of contracted services within the area of responsibility on a project basis regarding quality, timelines, costs, etc. in the PV subunit, in alignment with the operational project management
  • Pharmacovigilance & drug safety, in alignment with the Global Head of PV
  • Clinical trial related PV (safety management plan, SAE-reporting and assessment, case narratives)
  • Writing and distribution of aggregate reports (PSUR, DSUR)
  • Post-authorization PV
  • Safety risk management planning
  • Risk analyses, signal detection
  • Specific safety studies (PASS, PMS, etc.)

Preferred Skills:

  • Special degree (certificate) in a clinical specialty or other relevant field of medicine, and/or substantial practical experience in a clinical setting.
  • Substantial practical experience in drug development, regulatory procedures and pharmacovigilance / drug safety
  • Substantial experience in planning, conducting, supervising and evaluating clinical trials
  • Ability to familiarise oneself with new scientific and medical areas and therapeutic area specifics as per demand within short periods of time.
If you would like to apply for this position, or would like a discussion about this, or any other role, please send your contact details, together with your curriculum vitae to: