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Salary
About This Role
As the Associate Director, 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 facilitates 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
- Complete assessment and medical review of post-marketing and/or clinical trial adverse event reports within regulatory and departmental timelines and in accordance with Biogen procedures and conventions:
- Ensures adequacy of recording, summarization, and handling of adverse events for marketed and developmental Biogen products
- Assesses seriousness and expectedness for reported adverse events
- Assesses company causality for relevant adverse events
- Ensures accurate coding of adverse events
- Ensures due diligence in characterizing adverse events
- Authors analyses of similar events for select serious adverse reactions
- Collaborates closely with Medical Coding on development and maintenance of Expected Terms Lists (ETLs) and other MedDRA code lists as required
- Monitors global case review activities to ensure adequate timeliness of medical review
- Liaises with program & product safety physicians to ensure consistency in approach to medical review as well as ensure focused oversight on critical areas related to ongoing safety analyses
- Conducts quality oversight of global case medical review activities outsourced to a vendor
- Provides consultation for medically related questions from participating vendors, affiliates, etc.
Who You Are
You are a graduate of a recognized, accredited medical school. You are a PV professional with a minimum of 3 years’ experience in drug safety setting within the pharmaceutical/biopharmaceutical industry or in a clinical setting. 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.
Qualifications
Required Skills:
- MD required
- Solid understanding of worldwide post-marketing and clinical trial adverse event regulations
- Strong ability to understand and evaluate technical, scientific and medical information
- Initiate collaboration with staff members to create an effective team environment.
- Demonstrate excellent communication skills
- Solid understanding of MedDRA coding
- Good computer skills and ability to learn new systems as they are implemented
- Ability to interact effectively with global staff of multiple disciplines within the company
- Working knowledge of cGCP and GVP regulations, 21CFR Part 11, MedDRA and HIPAA
Preferred Skills
- Experience with ArisG
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Additional Information
Why Biogen?
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
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.
