What are the responsibilities and job description for the Safety Associate Pharmacovigilance (Contract) position at Zentalis?
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
Salary : $40 - $80