Safety Associate Pharmacovigilance (Contract)

SAFETY ASSOCIATE PHARMACOVIGILANCE Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its investigational first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care. POSITION SUMMARY: The Safety Associate, Pharmacovigilance completes ICSR review and performs SAE Reconciliation for the Client. This is a contract/temporary position. ESSENTIAL DUTIES AND RESPONSIBILITIES: Review triage case assessment emails for accurate reporting timelines. Perform ICSR QC on behalf of the Client and send for Medical Review. Update cases for accuracy as needed and return to safety vendor. Review updated cases from safety vendor. Confirm updated cases for approval. Maintain Daily Case Review List. Send CIOMS/XML cases to the business partner(s) and/or other manufacturers. Send the safety vendor monthly listings to the Clinical and Medical Monitors for each Investigative Product and study. Attend weekly safety vendor, PV, and clinical trial team meetings, as assigned. Perform safety vendor oversight, as requested. Provide case processing out of office (OOO) coverage based on consultants’ availability. Ensure compliance with internal SOPs, global pharmacovigilance regulations, and inspection readiness activities. Participate in audits and inspections by providing support related to case review and data quality. Maintain up-to-date knowledge of pharmacovigilance regulations, safety databases, and medical review processes. Other PV responsibilities as assigned Comply with Company procedures/SOPs and support updates to procedural documents as needed KNOWLEDGE/SKILLS/ABILITIES REQUIRED: Required: BA, BS, or MS degree in scientific or health related discipline, or PharmD, preferred Minimum of 5 years in Pharmacovigilance Self-motivated, independent, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously Ability to interact constructively and efficiently with co-workers and management within and across departments Ability to resolve day-to-day issues efficiently while maintaining compliance Proactive approach to problem solving Excellent, clear, and concise writing skills Excellent, clear, and concise verbal presentation skills Proficiency in using Argus Safety database, Microsoft Outlook, Word, Power Point, Excel, SharePoint, and Adobe