Medical Director of Global Drug Safety

3 days ago


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

Job Description

The Medical Director, Global Drug Safety and Pharmacovigilance will lead the implementation and coordination of safety surveillance procedures for products. The successful candidate will have a strong background in pharmacovigilance, with a minimum of 3 years of experience required.

Main Responsibilities

  • Develop and lead safety activities and benefit-risk strategies throughout the life-cycle for assigned products.
  • 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.
  • Act as safety lead on assigned projects with Business Partners, Vendors, Clinical Development Teams and Post Marketing Project Teams.

Qualifications

  • 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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