Medical Director - Safety

We are looking for a curious and talented physician eager to expand their expertise in drug safety. This role offers a unique opportunity to deepen your knowledge in pharmacovigilance while contributing to patient safety in a dynamic and collaborative environment. For skilled and motivated profiles, the position provides excellent opportunities for professional growth.

Key Responsibilities:

• Accountable for all aspects of safety related primarily to assigned marketed products
• Acts as responsible DSP assigned to projects in early development
• Leads the cross-functional Safety Management Team (SMT) for assigned products; responsible for the integration, analysis, and interpretation of safety information from all sources, including preclinical throughout life cycle product management.
• Coordinates and ensures good quality presentation by the SMT at the Drug Safety Committee (DSC), with an accurate review of the safety profile of the product including presentation of implemented safety measures and SMT recommendations
• Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information
• Responsible for the preparation of aggregated periodic safety reports (DSUR, PSUR/PBRER), Reference Safety Information (RSI) section of the Investigator Brochure (IB) and contributes to other key regulatory key safety documents such as RMP
• Responsible for medical review of adverse event reports received from all sources for assigned projects/products to ensure proper coding, seriousness, expectedness and causality assessment and request medically relevant follow up information for proper documentation and evaluation of the cases
• Responsible for responses on safety inquiries from regulatory authorities
• Supports the management of regulatory Heath Authority inspections

Qualifications:

• Doctor of Medicine degree with at least 5 years' experience in global drug safety in the pharmaceutical or biotechnology industry
• Full understanding of post-marketing adverse experience reporting systems, experience in product safety monitoring and preparation of post-marketing regulatory safety reports/documents
• Excellent medical writing and presentation skills
• Excellent interpersonal, communication and negotiation skills
• Excellent organizational and planning capabilities and ability to meet timelines