Lead Pharmacovigilance QC Specialist
About the position The Lead Pharmacovigilance QC Specialist provides strategic oversight of end-to-end case safety quality, ensuring compliance and quality in adverse effects, including individual case safety report (ICSR) adverse events, product complaints (PC), and special reporting situations (SRS) for UTC's developmental and marketed products. As the lead, this role drives process improvements, and strengthens overall ICSR quality including retrospective review and ensuring proactive corrective/preventive actions are implemented to support safety surveillance and benefit-risk management. Responsibilities • Evaluate and ensure appropriate quality standards and adherence to case processing procedures. • Provide strategic oversight of end-to-end case safety quality. • Ensure compliance and quality in adverse effects reporting. • Drive process improvements in ICSR quality. • Implement proactive corrective/preventive actions to support safety surveillance. Requirements • Bachelor's Degree in a related field such as chemistry or biology, or BSN, and 8+ years of experience in pharmacovigilance in either case processing or quality assurance of ICSRs. • Master's Degree in a related field such as chemistry or biology, and 6+ years of experience in pharmacovigilance in either case processing or quality assurance of ICSRs. • 3+ years of experience in vendor management and oversight. • Previous experience using Argus (preferred) or other safety databases. Nice-to-haves • Master's degree in a related field such as chemistry or biology. • 2+ years of experience in clinical trial or product development. • Knowledge of data entry processing, from start to finish (QC, medical review, regulatory submissions). • Prior clinical or post marketing experience. Benefits • Medical, dental, and vision coverage. • Employee wellness resources. • Savings plans (401k and ESPP). • Paid time off & paid parental leave benefits. • Disability benefits. Apply tot his job