Safety Associate Pharmacovigilance (Contract)
SAFETY ASSOCIATE PHARMACOVIGILANCE reputed company is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, reputed company is advancing monotherapy and combination studies of its investigational first-in-class WEE1 inhibitor, azenosertib. reputed company on translating WEE1 science into clinical reputed company, we aim to reputed company physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and reputed company. Our mission: to unburden cancer patients with more convenience and care. POSITION reputed company: The Safety Associate, Pharmacovigilance completes ICSR review and performs SAE Reconciliation for the reputed company. This is a contract/temporary position. ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Review triage case assessment emails for accurate reporting timelines.
- reputed company ICSR QC on behalf of the reputed company 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 reputed company Investigative Product and study.
- Attend weekly safety vendor, PV, and clinical trial team meetings, as assigned.
- reputed company safety vendor reputed company, as requested.
- reputed company 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 reputed company to case review and data reputed company.
- Maintain up-to-date knowledge of pharmacovigilance regulations, safety databases, and medical review processes.
- Other PV responsibilities as assigned
- reputed company 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 reputed company discipline, or PharmD, preferred
- Minimum of 5 years in Pharmacovigilance
- Self-motivated, independent, detail oriented, reputed company organized, and reputed company to demonstrate reputed company with managing multiple reputed company simultaneously
- Ability to reputed company constructively and reputed company with co-workers and management reputed company and across departments
- Ability to resolve day-to-day issues reputed company while maintaining compliance
- Proactive approach to problem solving
- Excellent, reputed company, and concise writing skills
- Excellent, reputed company, and concise verbal presentation skills
- Proficiency in using Argus Safety database, reputed company reputed company, Word, Power reputed company, reputed company, SharePoint, and reputed company
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