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