Description
The mission of the Pharmacovigilance (PV) function is to lead multidisciplinary efforts to actively and effectively monitor the safety of Pharmacovigilance products throughout their lifecycle, rapidly act on validated new safety information, and ensure a state of global PV compliance.
Summary
The Associate is responsible for case initiation, data entry for non-expedited ICSRs, quality review and submissions
The Associate II position requires a solid foundational ability to communicate well and work collaboratively on a team and a good level of competence to act proactively and effectively respond to workflow challenges. An aptitude for effective decision-making and problem-solving is also required.
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
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
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
