Medical Review Specialist Job

MEDICAL REVIEW SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in SOUTH SAN FRANCISCO, CA.

WHAT YOU'LL BE DOING:

- The Medical Review Specialist will assist in completion of medical review for the Drug Safety Risk Management department.
- Perform medical and quality reviews of completed SAE reports received from contract drug safety vendors (CROs) and transmit reports to business partner per safety data exchange agreement timelines.
- Exercise judgment and use of knowledge of FDA and ICH guidelines and product labeling in performing SAE case assessments and reviews.
- Generate appropriate queries to sites and/or contract drug safety vendors (CROs) to complete and clarify SAE case information, and exercises judgment in determining when cases are complete and ready to close.

WHAT YOU NEED TO BRING TO THE TABLE:

- BS/BA in Scientific or Medical field
- Must have working knowledge of ARISg database.
- The ideal candidate should have a general understanding of drug development, drug safety reporting, as well as medical communications practices, and an appreciation for the importance of regulatory compliance
- Strong computer, including Microsoft Office skills, and database skills
- Requires strong attention to detail and a high commitment to the quality of all projects and accountability for deliverables
- Positive approach to work projects and constructive, supportive interactions with colleagues

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a DayCLINICAL

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