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Title: Manager, Safety & Pharmacovigilance
Location: Bethesda, MD
Client:
Our client’s health servicing capabilities include Biopharmaceutical Development Support, Health Information Services, and Health/Environmental Assessment. This unique combination of services offer customers a broad range of expertise, and provide critical technical support to government and private sector clients engaged in vital health related research.
Opportunity:
Medical professional sought to manage the Safety and Pharmacovigilence specialist team in support of clinical trials. Projects include developing and conducting SAE training for clinical research sites around the world. Frequent verbal and written client contact regarding status updates, reporting timelines, procedures and problem resolution is required.
Responsibilities:
Responsibilities include, but are not limited to:
Management of associates / specialistsReviewing/coding adverse eventsDrafting IND Safety reports or MedWatch reportsProviding clinical site support for SAE reportingReviewing safety reporting requirements of clinical protocols.
Qualifications:
MS degree or higher in nursing or other health-related field5 or more years of clinical research experience Management experience required.Position necessitates strong process management and customer service skills with ability to handle multiple and competing deadlines in a rapidly changing environment. Knowledge of GCP and experience in developing and/or conducting training is essential. Familiarity with MedDRA coding is a plus. Must have excellent oral, written and computer skills.
As a professional search firm, we will only be responding to inquiries that most closely align with the requirements specified above. Please include position ID (Manager, Safety and Pharmacovigilence: CC 1274) in the subject line of your correspondence and forward your credentials in confidence as an attached Word document to recruiter6@ccesearch.com.
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