Qppv Specialist
??????, S01, SA, Saudi Arabia
Job Description
Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.
Job Summary
We are looking for a dedicated
QPPV Specialist
to join our dynamic Pharmacovigilance team. The ideal candidate will be responsible for ensuring the safety and efficacy of our products, as well as maintaining compliance with regulatory requirements.Key Responsibilities:
+ Ensure the PSMF &PSSF are accurate, up-to-date, and aligned with SFDA requirements. + Manages timely collection, assessment, and submission of ICSRs to the SFDA within legal timelines. + Ensure continuous monitoring of safety signals and management of emerging safety issues. + Act as the single PV contact point for the SFDA and PV inspections (24/7 availability). + Ensure compliance with all national pharmacovigilance requirements, risk minimization measures, and safety communication obligations. + Ensure timely SFDA submission of PSUR/PBRER, RMP, DHPC, and any safety-related regulatory requests. + Create and maintain local PV SOPs covering all SFDA-required PV activities. + Participate in audits, CAPA planning, and implementation of corrective/preventive measures.
Requirements
+ Bachelor's degree or higher in Pharmacy or Medicine + Licensed by the Saudi Commission for Health Specialties
+ Full-time resident in Saudi Arabia (KSA)
+ Pharmacovigilance experience preferred
+ PV training in ICSR processing and MedDRA coding preferred
+ PV training in signal detection preferred
+ Knowledge/training in PSUR/PBRER, RMP, PSMF, and KSA PV regulations preferred
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Job Detail
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Job IdJD2218594
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job Location??????, S01, SA, Saudi Arabia
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EducationNot mentioned