Pharmacovigilance Associate II

Key Responsibilities

• Case Initiation and Processing
• Monitor the BPV Inbox and Argus safety database for receipt of safety information routinely throughout the business day.
• Promptly review all relevant incoming items, using source document(s) to assess whether the case is valid and checking for duplicate cases; initiate all initial reports into the safety database per appropriate work instruction.
• Perform data entry for all non-serious ICSRs and all serious, non-expedited ICSRs (serious ICSRs with no regulatory submissions), ensuring timelines are met.
• Ensure all pending actions are completed and earliest received cases are prioritized; leverage email classification systems to categorize and prioritize incoming cases.
• Process follow up cases / previously reported events.
• Confirm receipt of case information by forwarding confirmation of safety reports received and providing Pharmacovigilance case numbers to appropriate partners.
• Perform quality review. Review the source documentation to identify data which should be entered into the safety database, including review of all applicable data entered to assure accuracy.
• Support submissions, including submitting reports to regulatory authorities and business partners and supporting the development of the cover letter and 1571 form for IND safety reports.
• Resolve submission problems as necessary.
• Conduct reconciliation of vendor / partners safety database with Pharmacovigilance safety database.

Education & Experience

• BA/BS degree in health or life sciences.
• Relevant experience in lieu of education accepted.
• 3+ years of pharmacovigilance experience.