Associate Director, Drug Safety and Pharmacovigilance Scientist

The Associate Director, Drug Safety and Pharmacovigilance Scientist is responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. The individual will provide interpretation and summaries of drug safety information and provide input in the generation of safety reports.

Requirements

• 4+ years' experience in Drug Safety / Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency
• Degree in a medical or healthcare related discipline like MD, PharmD, RN or PhD.
• Excellent knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines
• Experience with medical drug safety assessments, drug safety surveillance and monitoring activities
• Experience with safety data collection and interpretation from clinical trials, literature and post market
• Experience with preparation of responses to Regulatory Authorities and experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approval
• Experience with the development and updates to Reference Safety Information, IB, Company Core Data Sheet and local labels
• Excellent verbal, written and presentation skills

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement savings plan
• Generous paid time off (including a summer and winter company shutdown)