Senior Pharmacovigilance Specialist
2 days ago
Biogen is seeking a highly skilled Senior Pharmacovigilance Scientist to join our Safety team. As a key member of our team, you will be responsible for managing Pharmacovigilance activities, overseeing safety operations of clinical trials, and driving the development of aggregate reports and risk management plans.
Key Responsibilities- Lead and support the signal management process for assigned products, including signal detection and documentation.
- Synthesize safety data from various sources for comprehensive signal evaluation.
- Manage the strategy, review, and finalization of key safety aggregate reports.
- Liaise with cross-functional teams to address safety queries effectively.
- Collaborate with Global Safety Officers on safety strategies for clinical trials.
- Oversee daily safety operations and develop safety management plans for trials.
- Ensure alignment of safety strategy and risk communications in investigational programs.
- Minimum 7 years of Pharmacovigilance experience with a focus on aggregate reports and safety signal management.
- Bachelor's Degree in a biological or natural science, or health care discipline (advanced degree preferred).
- Proficiency in MedDRA terminology and its application.
- Strong computer skills, including advanced proficiency in MS Excel.
- Demonstrated analytical prowess and problem-solving capabilities.
- Capable of navigating a high-energy setting with numerous priorities.
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission.
Why Join Us?We are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.
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