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Global Medical Safety Director
Planet PharmaGhent, Flemish Region, Belgium27 dagen geleden
FunctieomschrijvingMD 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
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 :
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Director Director Safety Safety • Ghent, Flemish Region, Belgium