Senior Pharmacovigilance Expert
3 days ago
About the Role
We are seeking a highly skilled Safety Data Analyst Lead to join our team at Biogen, Inc. in this key role of Senior Pharmacovigilance Expert.
In this position, you will be responsible for leading safety signal management activities and overseeing the process for aggregate reports (PSURs, DSURs, Line Listings, RMPs). You will also respond to safety questions from internal and external stakeholders, review medical and scientific literature for safety information, and support Clinical Trial PV medical activities.
Key Responsibilities
- Lead the signal management process for assigned product(s) and evaluate safety data and signals as part of ongoing pharmacovigilance activities.
- Develop and implement strategies for responding to safety questions from regulatory authorities.
- Oversee Aggregate Report management, including strategy, review, and finalization of aggregate safety reports for assigned products.
- Collaborate with Global Safety Officers and other Safety MDs for assigned investigational programs.
What We Offer
Our company offers a competitive salary range of $140,000 - $170,000 per year, based on experience.
Qualifications
- Bachelor's Degree in biologic or natural science, or health case discipline; or Advanced degree (PhD, MPH, NP, PharmD, etc.) required.
- Significant and proven Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management.
- Strong leadership skills and ability to prioritize independently with minimal supervision.
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