Sr Manager, PV QualityApply Now
Location: Cambridge, Massachusetts 02139
Employment Type: Contract
Contract Length: 9+ months
Job Summary: This individual will be a key contributor in growing and shaping the company’s global R&D Quality Program (GCP/GLP/GVP/CSV).
- Participate in the development of Pharmacovigilance System support of global R&D activities in the region.
- Proactively partner with members of global and regional Research and Development organizations to support the successful and compliant execution of R&D activities.
- Develop and/or provide input in the development of RDQ Quality Audit Schedules and Annual Audit Plans.
- Provide QA consultation support for CSPV, RA and Medical Affairs/ Medical Information
- BS/BA, MS or PhD and a minimum of 12, 10, 9 years’ experience, respectively, in Biotech, Pharma or Clinical Research Organization.
- 10+ years’ experience in Pharmacovigilance QA in a global environment.
- Strong knowledge of relevant FDA, EU, ICH Pharmacovigilance guidelines and regulations and local legislation.
- Experience with Device Vigilance, EU and FDA
- Basic knowledge of relevant FDA, EU, ICH GCP guidelines, and local/regional GVP regulations/legislation.
- Experience working with CROs, vendors, and relationship management preferred.
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