Medical Director, Global Medical Safety - #19544476
The Global Safety Physician will be responsible for global pharmacovigilance for investigational and/or marketed products, including review and analysis of safety data, design of clinical trials, identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products. The Global Safety Physician will represent Biogen Safety in internal and external meetings. The Global Safety Physician can be appointed as the Global Safety Officer for a specific product. Responsible for keeping upper management informed of safety issues.
The Global Safety Physician will demonstrate the flexibility and capability to function at a high level across multiple disease areas and will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds through their life cycle. This person will also interact with multiple levels of management within Biogen, external stakeholders in the medical community as well with global regulatory authorities.
1. Manage safety surveillance for assigned products
a. Collaborate with PV scientists and other stakeholders
b. Conduct analyses of safety trial data.
c. Ensure adequacy of summarizing and handling of adverse events for investigational and/or marketed Biogen products including decisions on seriousness, expectedness, and causality.
2. Provide safety strategic leadership for clinical development programs
a. Integrate the safety scientific component to build a strategic framework for clinical development plans.
3. Develop and maintain relationships with counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Quantitative Sciences, Translational Sciences, Worldwide Medical.
4. Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timelines and timelines set by regulatory authorities.
This position is ideally based in Cambridge, MA (USA). It could potentially be based in North Carolina (US) or Maidenhead (UK).
- MD required; subspecialty focus in neuroscience, psychiatry, immunology, rare diseases preferred
- Minimum 7+ years experience in the pharmaceutical industry or clinical care setting; ideally 5+ years of overall experience specific to pharmacovigilance.
- Prior experience in clinical trials; academic and/or industry.
- Knowledge of pre- and post- marketing US and EU regulations
All your information will be kept confidential according to EEO guidelines.