Posted in Information Technology about 2 hours ago.
Type: Full Time
Job Description
About This Role
The Senior Manager, Drug Safety Adverse Events of Special Interest (AESI) and Medical Evaluation is accountable for supporting and executing the established strategies & processes to ensure AESI ICSRs and Medical Review of all ICSRs are managed with a high degree of quality and compliance and conducted in compliance with regulatory requirements and corporate and departmental procedures. The Senior Manager is responsible to ensure complete and accurate reporting of adverse event data to regulatory agencies and clinical trial investigator sites worldwide, as applicable. The Senior Manager provides quality oversight to Contract Research Organizations (CROs) involved in AESI case handling and ICSR medical review. Other key responsibilities include collaboration with a wide range of cross-functional teams such as Global Case Management (GCM), Global Medical Safety (GMS), Medical Coding, Medical Affairs, Technology and Data Insights (TADI), etc.
What You'll Do
Who You Are
You are a PV professional with a clinical background and a minimum of 4 years' experience in the pharmaceutical/biopharmaceutical industry. You have a strong background in PV and handling global ICSRs, with demonstrated ability to work collaboratively and effectively in a fast paced environment and with individuals at all levels within the organization. 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
Education and Experience Requirements:
Additional Information
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.
PDN-9d4fa0f8-5c14-4a52-a5c9-47cc15356337
Biogen |
Biogen |
Biogen |