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Drug Safety Physician

Trenton Metro Area, NJ

Post Date: 04/04/2017 Job ID: JN -042017-18744 Job Type: Clinical
  • MD with at least 5 years of drug safety experience
  • Advanced knowledge of FDA, PSURs, INDs, Annual Reports, and Operations
  • Provides leadership to the drug safety strategy and expertise in safety matters
  • Oversight of safety review committees.
  • Provides information to colleagues to ensure that safety information regarding drug products is medically appropriate
  • Prepares/reviews the safety components of protocols, investigator brochures, and annual reports; contributes to safety portions of IND/CTA/NDA documents, review clinical study protocols, clinical study reports, investigator brochures, annual IND reports, IND Safety Amendments, CRF design, SAE form design, and SAE submissions to health authorities.
  • Collaborates with global partners analyze safety aggregate information
  • Reviews Adverse Events (AEs) and Serious Adverse Events (SAEs) provided by case managers and provides Safety Medical Reviewer assessment

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