About This Role
As the Associate Director, ICSR Medical Evaluation you are responsible for the medical content and medical evaluation of individual case safety reports (ICSRs) across the company’s product portfolio, inclusive of post-marketing and clinical trials. You are accountable to ensure the consistent, timely and accurate assessment of adverse event reports in accordance with regulatory and departmental timelines, and you facilitate timely discussion and communication of information related to safety signal evaluation. You also serve as a medical resource with collaborations across the Biogen Safety and Benefit Risk (SABR) organization including global medical safety, safety signaling, global case management, and medical coding.
What You’ll Do
Who You Are
You are a graduate of a recognized, accredited medical school. You are a PV professional with a minimum of 4 years’ experience in a drug safety setting within the pharmaceutical/biopharmaceutical industry. You have demonstrated ability to apply sound clinical judgement, act decisively on sensitive safety topics, operate independently with minimal supervision and demonstrate expertise in global ICSR handling from intake to distribution.
Education and Experience Requirements:
Why Biogen?
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. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, 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. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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