Medical Director of Global Drug Safety
3 days ago
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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