Senior Pharmacovigilance (PV) Principal Scientist
A global force in the biotechnology industry is seeking to hire a Senior-level PV Scientist for a 6-month contract. There is a strong likelihood of this role converting to full-time employment but decision will be made based on contract performance.
The Senior PV Principal Scientist will be responsible for: 1) provide support and oversight of pharmacovigilance operational activities for designated compounds, with lead responsibilities when acting as the Global Safety Leader. 2) Contribute to development of safety exchange agreements for co-development projects. 3) Review and provide functional area expertise for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents. 4) Providing investigator and monitor training on safety procedures. 5) Assist with writing and maintenance of the Safety Monitoring Plan. 6) Perform ad hoc analyses (e.g.). In response to regulatory queries.
Duration: 6-month CONTRACT (possible conversion to FTE)
Compensation: $95-100 per hour
Location: Cambridge, Massachusetts
- Education: Bachelor's degree required. Advanced degree or specific pharmacovigilance qualification preferred (MD, PhD, and PharmD).
- Must have 9-20 years of drug safety/pharmacovigilance experience (based on education level)
- Excellent databases and coding skills including ability to perform advanced searches
- In depth knowledge of clinical trial methodology, pharmacovigilance regulations, safety profile and risk/benefit analysis.
- Critical thinking and decision making skills
- Ability to review, analyze, interpret and present complex data to a high standard
- Must be willing to conduct at least 5-10 trips per year (domestic & international).
Sthree US is acting as an Employment Business in relation to this vacancy.