PV Operations Manager

Cambridge , MA

Posted: 08/28/2018 Employment Type: Contract Industry: Life Sciences Job Number: 227232

PV Operations Manager

Location: Cambridge, MA

Duration: 6+ months

Job Description:
  • Provides vendor management oversight and review
  • Participates in the review and execution of PV Operations safety data collection strategy
  • Maintain a state of inspection readiness
  • Review and monitoring of compliance through various monitoring reports and other oversight activities 
  • Participates in internal audits and global regulatory inspections

  • Bachelor’ s degree required/Master’ s degree preferred
  • 5-7 years of direct hands on Drug Safety and Pharmacovigilance experience
  • Vendor management experience
  • Knowledge of FDA, ICH, EU Regulations
  • Experience using ARISg, Argus or other Safety Database
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