Global Medical Safety Director

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