JVT Advisors

AD, PV Scientist

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Location: Cambridge, Massachusetts 02139
Employment Type: Contract

Job Description

Contract Length: 12+ months

Job Summary: The PV Scientist will be a key contributor focusing on strategic input, support in clinical trial, perform signal management activities and operational support for all the company’s products throughout the life-cycle. In this new role, the successful candidate will be responsible for the oversight of PV activities, vendor and alliance management, and ongoing process improvement.

 

Responsibilities:

  • Providing therapeutic area PV support for the company’s developmental products in close collaboration with senior PV, Clinical and Medical personnel.
  • Oversight of day to day PV operational activities for the company’s investigational products.
  • Develop and maintain processes that will ensure excellence in global case reporting and assessment, demonstrating accuracy, consistency and compliance with applicable global pharmacovigilance regulations.
  • Oversight of vendor in case management and aggregate reports.
  • Review and provide PV therapeutic area input for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents.
  • Represent Pharmacovigilance on clinical teams and initiatives both within and across functional areas.

Requirements:

 

  • Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background
  • Minimum 8 years relevant medical, scientific/clinical, or pharmaceutical experience, including at least 4 years’ experience in PV – experience in vaccine development is required
  • Knowledge of MedDRA terminology and its application
  • Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex safety information
  • Experience in the preparation and authoring of individual and aggregate safety reports

 

Ovrille Gonsalves

Recruiting Lead

Ovrille is responsible for full lifecycle recruiting for JVT’s clients across several industry verticals. He supports the Contract Recruiting team, and specializes in identifying temp (contractual) and temp-to-perm resources for JVT’s clients.

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