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Global Medical Safety Director

Global Medical Safety Director

Planet PharmaGhent, Flemish Region, Belgium
27 dagen geleden
Functieomschrijving

Job Title : Global Medical Safety Director

Type : Permanent, Full-Time

Location : Belgium or Switzerland

Summary :

Our client is a Commercial Global Biotech with drugs on the market in several locations worldwide! Due to continued success and growth, they are looking for a Medical Safety expert (MD) as part of their global operations.

Responsibilities :

  • Provide strategic medical safety leadership and practical contributions for product portfolio
  • Perform safety signal management and benefit risk assessment activities as well as other regular and / or ad-hoc aggregate safety data reviews as needed for assigned product(s)
  • Lead cross-functional teams to perform regular and / or ad-hoc review of existing and emerging aggregate safety data for assigned product(s)
  • Contribute to the development of the overall safety governance structure and activities
  • Provide safety strategies and deliver accurate, timely and high quality safety contributions for the preparation of relevant sections of regulatory submission documents globally (e.g. ISS, SCS, narratives) for assigned product(s)
  • Prepare and / or review safety sections of clinical / regulatory documents (including study protocols, IBs, Clinical Study Reports, or ICFs)
  • Provide medical safety support for the preparation of responses to regulatory authority inquiries. Assure that safety information is timely, complete, and accurate
  • Lead the overall preparation of periodic safety reports (e.g. PSUR, DSUR); provide medical safety content and ensure consistency and quality of these documents
  • Oversee the medical assessment of individual case safety reports (ICSR)
  • Confirm criteria and content for expedited reporting and unblinding (e.g. SUSAR or urgent safety issues)
  • Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB)
  • Provide medical safety contributions at internal audits and regulatory inspections

Qualifications :

  • MD degree or equivalent required
  • At least 7 years of relevant experience in the pharmaceutical / biotech industry with at least 5 years in pharmacovigilance / drug safety (global experience is a plus)
  • Working knowledge of relevant pharmacovigilance regulatory requirements and guidance documents
  • Demonstrated ability to perform medical assessments of safety data from multiple sources
  • Experience with authoring complex documents and contributing to regulatory submissions
  • Knowledge of adverse event reporting systems
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    Director Director Safety Safety • Ghent, Flemish Region, Belgium