Medical Reviewer

Proclinical is currently recruiting for a Medical Reviewer with a biotechnology company located in Cambridge, MA.

Job Responsibilities:

• Completes assessment and medical review of post-marketing and/or clinical trial adverse event reports within regulatory and departmental timelines
• Ensures adequacy of recording, summarization, and handling of adverse events for marketed and developmental products
• 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

Skills and Requirements:

• Minimum educational level necessary to perform the job (High School diploma, Assoc Degree, Bachelor's Degree, Masters, PhD)
• 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.

If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at 267-297-3257.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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