Quality Assurance Associate (s846)

  • Contract Duration: 12+ months, with potential to extend
  • Clinical
  • Bridgewater, NJ

Website Lenox Executive Search

Description

Lenox Executive Search is looking to hire a Quality Assurance Associate for a contractual position with one of our long standing, global pharmaceutical clients. This is one year contract with the possibility of extension.

Responsibilities of a Quality Assurance Associate:

  • Performs quality reviews and investigations on PV outputs/deliverables such as but not limited to: Individual Case Safety Reports (ICSRs), PSRs, Scientific Literature screening.
  • Contributes to process improvement initiatives across the organization such as (but not limited to):
    – Assisting in RCA investigations.
    – Supporting the CAPA program.
    – Assisting in the facilitation of the CAPA plan,
    – Review, present results to various client groups, and verify corrective action
    implementation,
    – Directly lead CAPA activities in case of complex multifunctional quality issue
  • Performs trend analysis and analyze effectiveness of corrective action and work with stakeholders to re-adjust CAPA as required
  • Preparation and release of regular QA reports presenting issues, root causes, KPI and metrics, proposed CAPA and their effectiveness, for escalation to the hierarchy and operational stakeholders

Qualifications of a Quality Assurance Associate:

  • Bachelor’s degree in life sciences or related field required; certified health professional degree preferred but not required (example Pharmacist, Pharm D or Bachelor of nursing degree)
  • Minimum experience of 5 years in local or global Pharmacovigilance activities including case processing, involvement in interaction with affiliates, training users and Health Authority interactions during regulatory inspection
  • Understanding of Pharmacovigilance processes, PV database system, Dictionaries required
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– The Lenox Executive Search Team