JVT Advisors

Sr Manager, PV Quality

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Location: Cambridge, Massachusetts 02139
Employment Type: Contract

Job Description

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).

 

Responsibilities:

  • 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

Requirements:

  • 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.

Eric Carmody

Business Development Manager Life Sciences

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