Drug Safety Associate Jobs

Job Title: Pharmacovigilance Operations Associate

Location: San Francsico, CA (Hybrid - 3 days onsite)

Duration: 12-Month Contract (with the possibility to extend)

Benefits - Medical, Dental, Vision

Summary:

The PV Operations Associate provides operational support to the US Patient Safety Clinical and Vendor Oversight teams to ensure proper performance of baseline PV compliance-based responsibilities. This is done through the implementation and regulation of global processes, local legislation, case investigation, and study management. Responsibilities are performed under the direction of the PV Operations Manager.

Responsibilities:

• Liaise and collaborate with vendor oversight teams to ensure external and internal stakeholder compliance
• Provide regular ICSR compliance updates, highlight potential risks or trends and escalate issues to Team Leads and US PS Leadership Support implementation of CAPAs and business units where required on appropriate CAPA to any findings
• Ensure any non-compliance or late ICSR from programs are identified and ensure deviations are filed in accordance with global processes
• Ability to review the late case(s) to determine root cause analysis (RCA) and corrective action preventative action (CAPA) as needed
• Performs Outbound Submission and Tracking (OST) for literature ICSRs and submits relevant documentation to the health authority
• Assists and collaborates with Global ICSR team to inform on US Affiliate ICSR compliance performance and risks
• Supports Late ICSR Investigation and Risk Mitigation Strategy
• Continuous review of ICSR compliance trends to inform risk mitigation strategy to avoid non-compliance for the US affiliate
• Perform Individual Case Safety Reports (ICSR) Activities
• Ensuring all US Medical Affairs (USMA) studies have been reviewed and assessed by PV Clinical Group
• Responsible for oversight, triage, and tracking of incoming study document review request
• Responsible for performing Case Transmission Verification (CTV)
• Supports all study management-related activities

Qualifications

• Degree in Life Science or related field (Preferred)
• Familiarity with project management software tools, methodologies, and best practices
• Minimum Bachelor’s degree (Preferred)
• Demonstrates expertise in computer skills and database experience (i.e Microsoft Office Suite and Google Applications )