Job Details

  • Title: QA Associate
  • Code: RCI-03370
  • Location: Bridgewater New Jersey (NJ) 08807
  • Posted Date: 01/11/2021
  • Duration: 11 Months
Talk to our Recruiter

  Job Description

The QA Associate in Global Pharmacovigilance Quality performs quality reviews on PV outputs/deliverables such as but not limited to: Individual Case Safety Reports (ICSRs), PSRs, Scientific Literature screening.

• Contribute to process improvement initiatives across the organization such as (but not limited to):
o assisting in RCA investigations
o assisting in the CAPA program and assisting in the facilitation of the CAPA plan,
o review, present results to various client groups, and verify corrective action implementation
o directly lead CAPA activities in case of complex multifunctional quality issue
• Perform 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

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