Senior Pharmacovigilance Medical Director

5 days ago


County Dublin, Ireland Cpl Resources - Science & Engineering Full time

Job Summary

We are seeking a highly skilled Medical Director, Global Drug Safety and Pharmacovigilance to lead our team in implementing and coordinating safety surveillance procedures for products. This is an exciting opportunity to work with cross-functional teams to develop benefit-risk strategies and ensure the safe use of pharmaceuticals.

The successful candidate will have a strong background in pharmacovigilance, with a minimum of 3 years of experience required. If you do not have pharmacovigilance experience, you must have at least 4 years of pharmaceutical experience in a scientific area such as clinical development, regulatory or medical affairs.

Duties and Responsibilities

  • Develop and lead safety activities and benefit-risk strategies throughout the life-cycle for assigned products.
  • Oversee, prepare, contribute, and/or review aggregate safety review documents.
  • Lead evaluation and management of signals emerging from any data source.
  • Presentation of safety signals to development team and Global Safety Committee.
  • Responsible for the medical review of all sources of safety information.
  • Contribute to safety labelling activities for products.
  • Provide medical support to the EU QPPV or other regional or local Qualified Person for PV.
  • Act as safety lead on assigned projects with Business Partners, Vendors, Clinical Development Teams and Post Marketing Project Teams.

Requirements

  • MD or equivalent degree with a minimum of 3 years of pharmacovigilance experience required.
  • Expert knowledge of EMA safety regulation, GVP, ICH Guidelines, and other applicable regulatory requirements and guidance documents.
  • Ability to evaluate, interpret and synthesize scientific data.
  • Highly self-motivated with a demonstrable passion for pharmacovigilance and strong interpersonal skills.
  • Excellent written and oral communication in English.


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