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Associate Director, ICSR-Medical Evaluation

Company: Biogen
Location: Cambridge
Posted on: September 16, 2020

Job Description:

Associate Director, ICSR-Medical Evaluation Cambridge, MA

Full-time

Department: Research & Development

Region: US

Company Description The Associate Director, Medical Evaluation is responsible for the medical content and assessment of post-marketing and/or clinical trial adverse event reports, and serving as a medical resource for the GSRS,GCM, AR & SS team,GSRS department, and other cross-functional teams as needed. This position ensures that consistent, timely, and focused medical review for safety cases is conducted according to regulatory and departmental timelines at the individual level, and facilitates timely discussion and communication of information related to safety signal evaluation.

Job Description  Completes assessment and medical review of post-marketing and/or clinical trial adverse event reports within regulatory and departmental timelines o Ensures adequacy of recording,summarization, and handling of adverse events for marketed and developmental Biogen products o Assesses seriousness and expectedness for reported adverse events.

Assesses company causality for relevant adverse events

Ensures accurate coding of adverse events and serving as a resource to the medical coding staff

Ensures due diligence in characterizing adverse events • Authors analyses of similar events for select serious adverse reactions • Monitors global case review activities to ensure adequate timeliness of medical review

Liaises with program & product physicians to ensure consistency in approach to medical review as well as ensure focused oversight on critical areas related to ongoing safety analyses

Conduct oversight activities of global case medical review quality

Provides consultation for medically related questions from participating vendors, affiliates, etc.

Qualifications  Graduate of a recognized, accredited medical school.

Minimum of 3 years’ experience in a drug safety surveillance setting within the pharmaceutical/biopharmaceutical industry or in a clinical setting.

Additional Information All your information will be kept confidential according to EEO guidelines.

Associate Director, ICSR-Medical Evaluation

Keywords: Biogen, Cambridge , Associate Director, ICSR-Medical Evaluation, Other , Cambridge, Massachusetts

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