Drug Safety Physician
Trenton Metro Area, New Jersey
- 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