Associate Medical Director, Medical Evaluation

Proclinical is currently seeking an Associate Medical Director for an 18-month contract role in a biotechnology company located in Cambridge, MA, but the position can be onsite or remote. Successful candidate will be 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 SABR GCM, AR & SS team, SABR department, and other cross-functional teams as needed.

Job Responsibilities:

• Ensure adequacy of recording, summarization, and handling of adverse events for marketed and developmental products.
• Assess seriousness and expectedness for reported adverse events.
• Assess company causality for relevant adverse events.
• Ensure accurate coding of adverse events and serving as a resource to the medical coding staff.
• Ensure due diligence in characterizing adverse events.
• Author analyses of similar events for select serious adverse reactions.
• Monitor global case review activities to ensure adequate timeliness of medical review.
• Liaise 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.
• Provide consultation for medically related questions from participating vendors, affiliates, etc.
• Participate in inspection readiness activities and regulatory inspections.
• Provide training on medical topics to the global case management team.
• Participate in operational excellence initiatives.
• Compliance with corporate and department SOPs and conventions while maintaining a working knowledge of global safety guidelines and regulations.
• Monitor marketed or investigational products and adhere to safety regulations worldwide.
• Train and mentor new/junior physicians and safety associates.
• Working knowledge of cGCP and GVP regulations, 21CFR Part 11, MedDRA and HIPAA.

Skills and Requirements:

• Graduate of a recognized, accredited medical school.
• 3+ years' experience in a drug safety surveillance setting within the pharmaceutical/biopharmaceutical industry or in a clinical setting.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Brendan Dunn at (+1) 646-481-1930 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

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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