Website Lenox Executive Search
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
– 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