Global Medical Safety Lead (MD) | Global Biopharmaceutical Role - This is a contract position
We are seeking an experienced Medical Safety Physician to take global ownership of safety strategy and benefit-risk oversight for products across both clinical development and post-marketing stages.
This is a senior, globally impactful role where you will act as the medical safety authority for assigned products, ensuring patient safety and supporting informed regulatory and development decisions.
Key Responsibilities
* Lead global medical safety strategy for assigned products across development and marketed phases
* Conduct signal detection, evaluation, and benefit-risk assessments
* Oversee and contribute to PSURs, DSURs, PBRERs, RMPs, and safety sections of regulatory submissions (NDA/BLA/MAA)
* Provide medical oversight of ICSRs, SUSARs, and expedited reporting decisions
* Present safety data to Data Safety Monitoring Boards (DSMBs) and governance forums
* Act as key safety contact for regulatory authorities and internal stakeholders globally
* Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Medical Affairs, and Pharmacovigilance Operations
* Contribute to pharmacovigilance systems, SOPs, audits, and inspection readiness
About You
* Medical Degree (MD or equivalent is required)
* Significant experience in pharmacovigilance / drug safety (typically 7+ years minimum)
* Proven expertise in:
* Signal detection and safety evaluation
* Benefit-risk assessment
* Regulatory safety reporting (PSUR, DSUR, RMP, etc.)
* Clinical trial and post-marketing safety oversight
* Strong experience working in global, matrixed pharmaceutical or biotech environments
* Confident communicator with the ability to engage with regulators and senior stakeholders
* Experience in both clinical development and marketed product safety strongly preferred
Why This Role
This is a high-impact opportunity to shape global safety strategy at product level, influence regulatory decision-making, and ensure the safe use of medicines worldwide. You will work at the interface of science, regulation, and patient safety in a highly collaborative international environment.
Ideal Profile
We are particularly interested in senior Safety Physicians, Global Safety Leads, and Medical Directors in pharmacovigilance who have operated at global level and are comfortable leading complex safety decision-making.