We're looking for a Medical Evaluation Associate Director, working in the Biotechnology/Medical Devices industry in Cambridge, Massachusetts, United States.
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.
We are offering Competitive Compensation and Benefits. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
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
Solid understanding of worldwide post-marketing and clinical trial adverse event regulations
Strong ability to understand and evaluate technical, scientific and medical information
Demonstrate excellent communication skills
Good computer skills and ability to learn new systems as they are implemented
Ability to interact effectively with global staff of multiple disciplines within the company
Working knowledge of cGCP and GVP regulations, 21CFR Part 11, MedDRA and HIPAA
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.