Are you looking to elevate your career to the next level with a rare disease focused organization? The PV Scientist will provide functional experience while supporting products for both developmental and marketed products. This is a great opportunity to gain internal and external exposure while taking your career to the next level.
- Review and provide experience for the developmental of protocols, IBs, CSRs, and other relevant documents.
- Participate in the coordination of signal detection and safety review activities.
- Assist with the writing and maintenance of the Safety Monitoring Plans.
- Ensuring the timely submission of US Adverse Events
- Support operational activities for designated compounds.
- Review of signal detection of products from their PV vendor
- 3+ years of related pharmaceutical/biotechnology industry experience
- Familiarity with FDA Regulations/ICH guidance
- Experience in pharmacovigilance, mainly reviewing Adverse Event and Periodic Reports