Pharmacovigilance Specialist

Main Responsibilities and Accountabilities: Required to act as Deputy (during absences) for the International Partner Markets (IPM) Pharmacovigilance (PV) responsible person and nominated to the Local Health Authority where applicable. Management of Individual Case Safety Reports (ICSRs) encompassing the handling, reporting, follow up and documentation in electronic systems. Reconciliation of ICSRs with relevant internal and external stakeholders, such as the medical information service provider, Global Case Management, Organized Data Collection Services (ODCS), and third parties (e.g., distributors, Patient Support Programs (PSPs), and Market Research Programs (MRPs)). Handling of Product Complaints and Medical Inquiries combined with potential ICSRs or Special Situations. Generates the corresponding Meeting Minutes with internal and external stakeholders Documents the testing of Local business continuity plan (BCP) as per company procedures. Organizes the regional PV Audit and Inspection lifecycle, in close liaison with PVRQA. Engages Local Quality Personnel to ensure an updated local PV curriculum in the Learning Management System (LMS). Updates the Document Management System (DMS) PV Standard Operating Procedures (SOPs), Work Instructions (WI) and relevant forms. Collaborates and monitors the deployment of PV training to internal and external stakeholders (including distributor personnel) Optimizes the storage and archival of physical and digital repository of PV related Documents and records. Maintains Local PV Platforms updated with the latest available information (Regulatory Intelligence tool, Reporting Requirements tool, among others) Supports IPM initiatives ad hoc as assigned by IPM Lead.

Job Qualifications and Experience Education Degree in Pharmacy with active registered License Experience Preferred 1 Year experience in Pharmacovigilance or Regulatory Affairs or Quality Competencies Good Verbal and Written communication skills in English and Spanish

Note: The interviews for this position will be conducted in English.