Company Summary: A small, growing CRO in the Rockville/Bethesda area in Maryland is currently seeking an experienced Safety and Pharmacovigilance Specialist to support their clinical research team. You will play a significant role in the preparation of safety reports for submission to the FDA.
The Safety and Pharmacovigilance specialist will be responsible for…
- Analyzing and processing of adverse events
- SAE reconciliation and preparation of IND safety reports
- Leading clinical and cross-functional teams
The Safety and Pharmacovigilance specialist should have the following qualifications…
- D. or D.O., RN, PhD, PharmD, or MPH with direct Drug Safety experience
- Knowledge of GCP and ICH guidelines
- Experience with CTC and/or MedDRA coding
- Preferred subspecialty in Infectious disease and/or Oncology
- 3+ years of pharma/biotech experience
