Job Title: Sr Assoc Pharmacovigilance Operations
Duration: 6 Months (PTE)
Location: 91320, Thousand Oaks, CA
Fully Remote - Any timezone
Purpose:
To support the safety surveillance process for our products by performing follow up activities with patients and HCPs of individual case safety reports. Ensure vendor compliance with approved processes and training requirements. Oversee case quality of US ICSRs (CT and PM) including analysis and reporting of trends in quality measures. Point of accountability for managing one or more key vendor relationships for ICSR processing. Case processing point of contact for case related activities with assigned business partners. Case processing point of contact for audit related activities related to case processing. Accountable for measuring quality against contractual safety agreements. Accountable FDA point of contact for ICSR reporting. Su...