Associate Director, ICSR Medical Evaluation

Job Description

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.

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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 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.

Qualifications

Education and Experience Requirements:

• Medical Degree required.  Graduate of an accredited Medical School with 2+ years in clinical setting preferred.
• 4+ years' experience in Pharmacovigilance/ Drug Safety.
• Strong proficiency and working knowledge of global pharmacovigilance regulatory requirements and Good Pharmacovigilance Practice (GVP).
• Strong proficiency and working knowledge of MedDRA dictionary.
• Strong analytical skills with the ability to review, evaluate, interpret and synthesize clinical and safety data in both written and verbal format.
• Strong proficiency in verbal and written communication with great attention to detail.
• Ability to work independently, manage priorities, build collaborative team relationships at all levels, and remain flexible to the needs of the teams/ projects. Must be able to work on multiple projects simultaneously.
• Ability to interact effectively with global staff of multiple disciplines within the company.
• Working knowledge of GCP and GVP regulations, 21CFR Part 11, MedDRA and HIPAA.

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.