Job Descriptions

POSITION SUMMARY: Act as Nationally Nominated Person for Pharmacovigilance in KSA (QPPV) and back up QPPV in Kuwait & Oman assuming the PV role as defined by national law. Support Pharmacovigilance related activities in GCC region and as required by Marketing Authorization Holders (MAH) and/or study sponsor, as applicable. Ensure maintenance of an appropriate PV, vigilance system and Risk Management in order to assure appropriate oversight for products within its responsibilities. MAIN RESPONSIBILITIES: Local Medical Safety Responsibility & Benefit Risk Management:Establish Product knowledge with focus on safety profiles, Therapeutic Area and Disease Pathway knowledge supporting the needs of the local Medical and Marketing organization in collaboration with the International Medical Safety leader or MSO and the Country Safety team lead (CSTL)/Local Safety Officer (LSO) if applicable. Aggregate reports: Provide medical input and insights for aggregate reports while undertaking local review and ensure the submission of Periodic Safety Update Reports (PSURs/DSURs), as applicable. Pharmacovigilance-Safety training support: Perform Pharmacovigilance training for Local Operating Company employees; Perform training for Local Operating Company employees covering follow-up process for concepts of special interest (Watchlist) as applicable; Manage Adverse Event and Product Quality Complaints (AE/PQC) trainings to distributors/vendors and translation of AE/PQC material, where needed. PV contract management: Manage local Pharmacovigilance Agreements(PVAs) and ensure local implementation, including Local Safety Unit (LSU) training and adherence to PVAs; Coordinate the provision of support for third party safety agreements locally e.g. local Vendor Agreements as necessary, seek support from central functions like PV Service and Technical Contracts Group and International PV(IPV) Affairs as necessary. Safety regulations: Detect & Report PV regulatory requirements for MAH and/or study sponsor as applicable. Support the review of new/revised safety regulations (for drugs non-medicinal products & Medical Devices in scope of responsibilities), evaluation of the impact on local processes and notification of appropriate global and regional groups via central PV policy tracker about new requirements and or updates. Local Safety compliance (PV and non-medicinal product safety) :Provide insights into metrics to CSTL/LSO, lead actions as needed, act as CAPA Content owner and subject matter expert, own actions as required - depending on topic; Procedural Document review from Subject Matter Experts and Area leads - depending on topic. Perform Impact assessments and action as required on local level - depending on topic; Provide content to the Pharmacovigilance System Master File (PSMF) contributions and data, as required, on time and in high quality, ensure accuracy Pharmacovigilance and Vigilance Service Provision: Collaborate with CSTL/LSO to ensure that day-to-day P

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