At a Glance
- Tasks: Lead global medical safety strategy and ensure patient safety for biopharmaceutical products.
- Company: Dynamic global biopharmaceutical company focused on patient safety.
- Benefits: Competitive salary, impactful role, and opportunities for professional growth.
- Other info: High-impact role with international collaboration and career advancement opportunities.
- Why this job: Shape global safety strategy and influence regulatory decisions in a collaborative environment.
- Qualifications: Medical Degree and 7+ years in pharmacovigilance with strong communication skills.
The predicted salary is between 80000 - 100000 £ per year.
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.
Global Medical Safety Lead in Birmingham employer: Planet Pharma
As a Global Medical Safety Lead at our biopharmaceutical company, you will be part of a dynamic and innovative team dedicated to ensuring patient safety on a global scale. We offer a collaborative work culture that values your expertise and provides ample opportunities for professional growth, including involvement in high-impact projects that shape the future of medicine. Located in a vibrant city, our company not only prioritises employee well-being with competitive benefits but also fosters an environment where your contributions directly influence regulatory decisions and patient outcomes.
