Vacancy expired!
Job Description
The Medical Director, Global Safety Physicianwill 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.
The Global Safety Physician will demonstrate the flexibility and capability to function at a high level across multiple disease areasand will be comfortable working in an entrepreneurial environment to advance the safety and biological understanding of compounds through their life cycle.
1. Manage safety surveillance for assigned products
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 based in Cambridge, MA (USA).
Who You AreYou are a proven leader in safety & pharmacovigilance. Youstrive on developing, executing and advancingsuccessful programs in development. You have experience working / leading high performing teams; providing the necessary guidance and mentoring for all to reach their goals.
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Qualifications
MD or MD/PhDrequired; subspecialty focus in neuroscience, psychiatry, immunology, rare diseases preferred- Minimum 3+years experience in the pharmaceutical industry or clinical care setting; ideallyspecific to pharmacovigilance.
- Prior experience in clinical trials preferred; academic and/or industry.
- Knowledge of pre- and post- marketing US and EU regulations
Additional Information
The Medical Director, Global Safety Physicianwill 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.
Vacancy expired!