Softworld PV Operations Manager in Cambridge, Massachusetts

PV Operations Manager

Cambridge , MA

Posted: 08/28/2018

2018-08-28 2018-10-24

Employment Type: Contract

Industry: Life Sciences

Job Number: 227232

Job Description

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

Requirements:

  • 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