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