PV Safety Specialist – Case Processing & Vendor Oversight

Jobtailor; San Diego (CA); On-site; USD 90,000 - 135,000; Full time

Job summary

Jobtailor in San Diego, CA is seeking a Pharmacovigilance professional with 5+ years in PV to oversee case processing, QC, and safety vendor coordination.

You will review triage emails, perform ICSR QC, ensure compliance with global PV regulations, and support audits and inspections while maintaining data quality and clear cross-functional communication. Proficiency with Argus Safety and MS Office is required.

Qualifications

• BA, BS, or MS in scientific or health-related discipline, or PharmD preferred.
• Minimum of 5 years in Pharmacovigilance.
• Ability to interact constructively and efficiently with co-workers and management within and across departments.
• 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.

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

Skills

Detail oriented

Multitask management

Cross-functional

Proactive problem solving

Writing skills

Verbal communication

Education

Science degree

PharmD preferred

Tools

Argus Safety

Outlook

Word

PowerPoint

Excel

SharePoint

Adobe

Job description

Jobtailor in San Diego, CA is seeking a Pharmacovigilance professional with 5+ years in PV to oversee case processing, QC, and safety vendor coordination.

You will review triage emails, perform ICSR QC, ensure compliance with global PV regulations, and support audits and inspections while maintaining data quality and clear cross-functional communication. Proficiency with Argus Safety and MS Office is required.