Pharmacovigilance Coordinator

·       Monitor the safety mailboxes for the receipt and triage of Adverse Events (AEs) and Special Situations for products.

·       Track receipt of the AEs and Special Situations, perform duplicate check, conduct follow-up, and complete the International Safety Surveillance Report (ISSR) Form and/or Medical Device AE Report Form for quality check by the LSO.

·       Submit the ISSR Form and/or Medical Device AE Report Form to Global Pharmacovigilance (PV) for central case processing and track receipt of the global safety case number.

·       Exchange AEs and Special Situations associated with medical enquiries with Medical Information (MI) and ensure that the case number is cross-referenced.

·       Exchange Mixed Product Complaint (MPC) with Quality and ensure that the case number is cross-referenced and the investigation report, if available, is received from Quality upon complaint closure.

·       Track reportable cases and ensure reports are received timely from Global PV for LSO submission to local Regulatory Authorities.

·       Perform reconciliation with internal/external parties per established periodicity: weekly, monthly, or quarterly.

·       Perform screening of local literature for AEs and Special Situations associated with client products.

·       Maintain vigilance training records for internal and external parties.

·       Track local vigilance quality documents to ensure that they are current, reviewed and updated periodically.

·       Track and follow-up on open deviations and corrective and preventive actions (CAPAs).

·       Lead the design and implementation of activities for World Patient Safety Day in September for JPAC.