Job Description

Currently I have an opening for a PV Systems Solutions & Innovations Associate located in South San Francisco, CA (Hybrid Schedule). Details for the position are as follows:

Technical Information:

• 6-month contract with potential for extension or conversion
• Onsite 2-3 days per week
• Pay: $40-$42.55 hourly

Job Description:

• The PV Systems Solutions & Innovations 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 implementation and regulation of global processes, local legislation, case investigation, and study management.
• Responsibilities are performed under the direction of the Senior Manager, PV Systems Solutions of Operations & Innovations.
• Perform Individual Case Safety Reports (ICSR) Activities
• Performs Outbound Submission and Tracking (OST) for literature ICSRs and submits relevant documentation to health authority
• Ensure any non-compliance or late ICSR from programs are identified and ensure deviations are filed in accordance with global processes
• Assists and collaborates with Global ICSR team to inform on US Affiliate ICSR compliance performance and risks
• Performs daily workflow coordination and initial review of cases that are processed by our internal teams
• Oversees the enrollment process and proper onboarding of GVP vendor
• Assists in the tracking and investigation of case processing related metrics
• Supports Late ICSR Investigation and Risk Mitigation Strategy
• Ability to review late case(s) to determine root cause analysis (RCA) and corrective action preventative action (CAPA) as needed
• 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
• Continuous review of ICSR compliance trends to inform risk mitigation strategy to avoid non-compliance for the US affiliate
• Liaise and collaborate with vendor oversight teams to ensure external and internal stakeholder compliance
• HS, AS, BS, etc. with 5+ years of experience in Pharmacovigilance (PV). Ability to come onsite 2-3 days per week.

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