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