MSI Pharma Inc. are working with one of the largest pharma companies on the west coast to source 3 PV operations associates for 12 month hourly paid contracts.
The PV Operations Associate provides operational support to the Clinical and Vendor Oversight teams to ensure proper performance of baseline PV compliance-based responsibilities. This is done through the implementation and regulation of the global processes, local legislation, case investigation, and study management. Responsibilities are performed under the direction of the PV Operations manager.
- Perform Individual Case Safety Reports (ICSR) tasks o Performs Outbound Submission and Tracking (OST) for literature ICSRs and submits relevant documentation to the health authority
- Ensure any non-compliance or late ICSR from programs are identified and ensure deviations are filed in accordance with global processes.
- Performs daily workflow coordination and initial review of cases that are processed by our internal teams
- Oversee the enrolment process and proper onboarding of GVP vendor
- Assists in the tracking and investigation of case processing related metrics
- Supports all study management related activities o Responsible for oversight, triage, and tracking of incoming study document review requests o Responsible for performing Case Transmission Verification (CTV)
- Ensuring all USMA studies have been reviewed and assessed by PV Clinical Group
- Partners with key stakeholders to ensure proper assessment and documentation of study related decisions
Education & Experience:
- Minimum Bachelors degree and 2-5 years PV experience.
- Degree in Life Science or related field (Preferred)
- Demonstrates expertise in computer skills and database experience (i.e Microsoft office Suite) (Preferred).
- Writing experience; science/medical writing highly desirable.