Senior PV Scientist serves as a product lead for Pharmacovigilance activities within the safety function.
The Senior PV Scientist team is responsible for overseeing and leading the process for safety signal management activities, aggregate reports responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities.
The Senior PV Scientist also serves as a Subject Matter Expert for safety and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information.
location: Cambridge, Massachusetts
job type: Contract
salary: $85 - 115 per hour
work hours: 9 to 5
- Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests.
- Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).
- Demonstrates leadership and interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
- Applies clinical judgment to interpret case information.
- Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes knowledge of case processing, expedited reporting rules, and safety database concepts. - Strong organizational skills, including the ability to prioritize independently with minimal supervision.
- Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems.
- Advanced degree preferred (PhD, MPH, NP, PharmD, etc.)
- Bachelor's Degree in biologic or natural science; or health case discipline
- Minimum 7 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management.
- Strong background in clinical trial drug safety is required.
skills: MS-WORD, MS-EXCEL, Drug Safety, AD (Adverse Events)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.