Director, Medical Safety Physician Product Lead

Das ist der Job

Ensure scientific accuracy, consistency, and compliance of all safety-related deliverables.

Darum lohnt es sich

This is a high-impact role offering the opportunity to shape global safety strategy, influence regulatory submissions, and contribute directly to patient safety in a dynamic international environment.

As a key member of the Global Medical Safety team, you will lead safety oversight for assigned products, with a particular focus o n early development progra ms.

You will partner closely with cross-functional stakeholders across Clinical Development, Regulatory Affairs, Quality, and Pharmacovigilance to ensure robust benefit-risk assessments and regulatory compliance throughout development and commercializatio n .

Maintain oversight of product safety profiles, benefit-risk evaluations, and signal detection activities. Chair and lead Safety Management Team (SMT) meetings, driving safety governance and decision-making. Act as the medical safety representative within cross-functional global development teams.

Represent Pharmacovigilance within clinical trial teams and contribute to study safety oversight.

Demonstrated ability to influence and collaborate effectively within cross-functional and international teams. #J-18808-Ljbffr Medical Safety Physician Product Lead (Director) We are seeking an experienced Medical Safety Physician Product Lead (Director ) to provide strategic medical safety leadership across the full product lifecycle.

Key Responsibiliti es Lead and drive global medical safety strategy for assigned products across all stages of development (Phase I–IV). Provide safety leadership for early development programs, ensuring robust safety approaches from first-in-human studies through proof-of-concept.

Support global regulatory submissions, including INDs, NDAs, and MAAs, by delivering high-quality safety input and documentation. Ensure execution of global pharmacovigilance activities in accordance with regulatory requirements and company processes.

Serve as a key safety contact for health authorities, including interactions related to regulatory submissions and safety inquiries. Lead the preparation, review, and approval of key safety documents, including DSURs, PSURs/PBRERs, Risk Management Plans, and safety sections of regulatory filings.

Provide strategic support for safety responses to regulatory agencies and inspection findings. Act as a subject matter expert during audits, inspections, and continuous improvement initiatives. Requirements Medical Doctor (MD) with clinical practice experience.

Significant experience in Pharmacovigilance, Drug Safety, or Medical Safety within the pharmaceutical or biotechnology industry. Strong knowledge of global pharmacovigilance regulations, including EU GVP and FDA requirements. Proven experience supporting global development programs and regulatory submissions.