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Senior Associate, PV and Clinical QA

  • Job type: Permanent
  • Location: North Carolina
  • Salary: Competitive
  • Job reference: ARTR121817548
  • Sector: EPM Scientific, Safety, Quality
  • Date posted: 18/12/2017
Senior Associate, Pharmacovigilance and Clinical Quality Assurance
  • Senior Associate, PV QA
  • North Carolina
  • Excellent Salary + excellent bonus + excellent benefits

A global biopharmaceutical company with a strong Respiratory, Neonatology, Rare Disease and Special Care pipeline is seeking a Senior Associate, PV QA as they are rapidly expanding. This company is a top 50 biopharmaceutical company in the world with a direct presence in over 26 countries.


The Senior Associate, PV QA will have the following responsibilities:

Reporting to the Director of Quality Assurance, the Senior Associate, PV QA Provide quality oversight of PVQA and Clinical Quality Assurance for the US region, ensuring that system audits are conducted, communicating any critical compliance risks noted from these activities to senior management, and ensuring that corrective actions are implemented.
  • Provide quality oversight as the expert for PVQA and Clinical QA matters.
  • Establish the audit program according to patient-risk and ensure corrective actions and investigations associated with this program are adequately evaluated and closed in a timely manner:
  • Develop and ensure Training for the PV and Clinical teams

The ideal candidate will have the following skill set:

  • GLP/ PV/GCP QA
  • 5+ years of applicable pharmaceutical experience and/or biotech pharmacovigilance and Clinical QA
  • 3+ years direct Clinical QA and PVQA auditing experience
 

 

 

 


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