SAFETY & PHARMACOVIGILENCE SPECIALIST

• 6 month temp to hire
• Hybrid - Bethesda, MD
• Medical experience is a must; BSN, Pharm D. but prefer MD or DO
• Prefer someone who has worked in industry
• Will accept foreign medical graduates and US medical grads with no experience
• 3 plus years of experience
• Case processing experience required

RESPONSIBILITIES
• Perform various tasks in support of clinical research including: adverse event analysis and processing, serious adverse event reconciliation
• Preparation of IND safety reports for submission to the FDA

• Safety document or data analysis
• Clinical trial site support
REQUIREMENTS
• M.D. or D.O from an accredited institution
• Infectious disease and/or oncology subspecialty highly preferred
• Must have knowledge of GCP and ICH guidelines
• Drug development/clinical trial experience essential
• Knowledge of CTC and/or MedDRA coding preferred
• Experience leading clinical and cross functional teams is a plus
• Must have excellent oral, written, presentation and computer skills
• 3+ years of pharmaceutical or biotech industry or academic experience