We are currently seeking a Pharmacovigilance Systems Associate for a prominent Pharmaceutical client of ours. This position is in South San Francisco, CA. Details for the position are as follows:
Job Description:
Job Description:
- Pay: 35/hr. No flexibility in pay.
- Length of Assignment: 6 months to start with potential for extension.
- Hybrid role: 3 days onsite, 2 days remote.
- Interview process: 1 virtual interview.
- 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.
- 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.
- Oversees the enrollment process and proper onboarding of GVP vendor.
- Assists in the tracking and investigation of case processing related metrics.