Team Member – Pharmacovigilance Full Time NEW

Job Responsibilities:Ensure the implementation and maintenance of good pharmacovigilance systemEnsure that Saudi Food and Drug Authority have the current contact information for the QPPV and Deputy. Will have direct access to the local/regional PSMF, if required and will be involved in the PSMF update activities. Management of Individual Case Safety Report (ICSR) from all relevant sources.Perform initial assessment of identified ICSR (validation, seriousness, expectedness, and causality). Being aware of and involved in the implementation of RMMs activities. Submission of all due reports (e.g., ICSRS, PSUR, RMPRMMS, etc.) to local authorities in a timely manner. Provides input to the preparation of any regulatory action to be taken in response to emerging safety issues (e.g., variations, emerging safety restrictions, DHCP communications etc.). Reviews, approves and signs-off the PASS protocol and any protocol amendments, if necessary for local /regional studies conducted in Saudi Arabia. Being involved in the review of protocol and study report and sign-off of protocols of post-authorization safety/efficacy studies (PASS/PAES) conducted in the Saudi Arabia. Processing of medical information inquires. Overseeing all aspects of pharmacovigilance in accordance with all applicable regulations, guidelines, and standard operating procedures (SOP).Promote, maintain, and improve compliance with pharmacovigilance legal requirements and maintain up-to-date knowledge of current PV regulations.Perform weekly literature searches for local publication To perform monthly Regulatory Intelligence screening and maintain the tracking system. To perform AE periodic reconcialtion MAHActing as a single contact point for the local authorities on a 24-hour basis.Involved in signal management activities including signal detection and validation. Oversight and maintenance of Pharmacovigilance Quality Management System including SOPs. Have sufficient authority to influence the set-up and performance of the quality system as well as pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements without the necessary accountability for the execution of the various activities. Collects or has access to compliance data (metrics) and evaluates KPIs. Ensure MAH has proper quality assurance and control mechanisms in place. Participates in the continuous improvement of the PV related quality system and the processes including self-inspection. Ensures deviations are documented and if necessary, the CAPA plan is executed Have an overview of safety profiles and emerging safety concerns for all products for which the company holds authorizations. Overview of pharmacovigilance agreements (SDEA). Conduct an annual or induction PV training for MAHS employees and new hires in Saudi Arabia. Preparing for pharmacovigilance inspections and audits. Review audit reports and follow findings (CAPAs) to ensure resolution. Ensure back-up procedures are appropriately maintained.To Perform all QPPV responsibilities. Requirements:Licensed healthcare professional – pharmacist, physician, or equivalentProven expertise in pharmacovigilance systems, drug safety regulations, and Good Pharmacovigilance Practices (GVP)Resident of Saudi Arabia & officially registered with the SFDA.