Safety Associate Pharmacovigilance (Contract)

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.

Knowledge/Skills/Abilities 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.