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Sr. Manager, Pharmacovigilance Quality, and Compliance

  • Job type: Permanent
  • Location: Boston
  • Salary: Competitive
  • Job reference: kyrh 89584
  • Sector: EPM Scientific, Quality
  • Date posted: 26/01/2018
Sr. Manager, Pharmacovigilance Quality, and Compliance

A growing Pharmaceutical company with products on market as well as a strong pipeline of candidates in phase 2 and 3 is currently seeking a Manager, Pharmacovigilance Quality, and Compliance. They have received international recognition and are expanding their headcount for 2018. This company is looking for hands-on individuals to contribute to their continued growth and success.

The Sr. Manager, Pharmacovigilance Quality, and Compliance will have the following responsibilities:

The Manager, Pharmacovigilance Quality, and Compliance will be heavily involved in supporting the Drug Safety and Pharmacovigilance Quality Systems including PV SOPs, CAPAs and inspection related activities. They will also manage the systems in relation to PV Documents/Aggregate reports such as PSURs and DSURs. The Manager, Pharmacovigilance Quality, and Compliance will also be responsible for implementing a Global PV Training strategy.
  • Support Drug Safety and Pharmacovigilance Quality Systems including: PV SOPs, CAPAs and inspection related activities
  • Manage the systems in relation to PV Documents/Aggregate reports such as PSURs and DSURs
  • Implement a Global PV Training strategy
  • Assist with internal audits
  • Point of contact for PV documentation
The ideal candidate will have the following skill set:
  • Bachelor’s Degree
  • Minimum of 5+ years industry experience
  • PV Quality and Compliance experience (GxP)
  • Strong knowledge FDA and other international regulations
  • Excellent communication skills
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