Proclinical is currently recruiting for a PV Scientist with a biotechnology company located in Cambridge, MA.
- Project management and authoring of aggregate safety reports such as PSURs, DSURs, PADERs, local reports in collaboration with the PV scientist Lead.
- Serves as a subject matter expert on relevant safety requirements, company policies/procedures related to pharmacovigilance activities, as well as aggregate reports knowledge.
- Support with process improvement; implements and maintains processes.
- Responsible for the Aggregate Reports Master Schedule and worldwide legislation overview (production, update, stakeholders review).
Skills and Requirements:
- Education Bachelor's Degree in biologic or natural science; or health care discipline. Advanced degree (PhD, MPH, NP, PharmD, etc.) preferred.
- Minimum 5 years industry experience, with a minimum of 3 years of PV experience.
- 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).
- Interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
- 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. Oversees and mentors less experienced PV Scientist staff.
If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at 267-297-3257.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.