Pharmacovigilance Specialist

Responsibilities

• To perform general administrative and operational activities related to PV activities (including case tracking, data entry, document filing, and archiving, in alignment with applicable SOPs/OPMs and using PV tools.
• To maintain PV databases and documentation by ensuring timely and accurate entry, tracking, and filing of safety-related information in relevant systems.
• To prepare, submit the PV documentation to regulatory authorities in accordance with local and global regulatory requirements and file as required.
• To act as liaison during the absence of one or more members of the PV team to ensure continuous coverage and operational support under the supervision of the Deputy LPV.
• To perform delegated activities related to the Special Access Program, ensuring compliance with established procedures and timelines.
• To assist in the preparation and review of PV compliance metrics, reconciliation reports, and related documentation with internal and external stakeholders.
• To participate in PV departmental and cross-functional meetings, and follow-up actions as required.
• To ensure that all PV-related activities are conducted in compliance with applicable SOPs, OPMs and codes of practice.
• To undertake any other PV-related activities as assigned to support the overall functioning of the Local PV Department.