Requirements
Educational qualifications include a Doctor of Pharmacy (PharmD) or Pharmacy Degree, along with relevant PV training courses. Experience required is 2-3 years as a Qualified Person Responsible for Pharmacovigilance (QPPV). Key skills include detail-orientation, prioritization, teamwork, SOP development, time management, problem-solving, organization, planning, presentation, strong communication in English and Arabic, and proficiency in MS Office.
Description
Date posted: Aug 19, 2026City: RiyadhCountry/Region: SAType of Contract: Full-time Employment / UnlimitedJob Requisition ID: 12455Pharmacovigilance Manager - Middle EastLPV - Middle East (Saudi Arabia, UAE, Kuwait, Qatar, Oman, Bahrain, Iraq, Syria, Lebanon and Jordan):The Local Pharmacovigilance Responsible Person (LPV) is a local role, i.e., responsibility for an affiliate and, if applicable, additional countries reporting into an affiliate. The LPV is responsible for the review of protocols for Cosmetovigilance (CV)/ Pharmacovigilance (PV)/Medical Device Vigilance (MDV); providing guidance and advice on required and desirable CV/PV/MDV activities to ensure compliance with appropriate regulatory, institutional, and local guidelines and regulations. This is done in collaboration with Regulatory teams in Middle East Countries as well as Global Safety (GS) in headquarters in Paris.The LPV works to maintain the high-profile image of the company with health authorities in Middle East Countries.The LPV supports the setup and implementation of CV/PV/MDV activities for studies, including internal and external collaborator/staff training, drafting and reviewing Standard Operating Procedures (SOPs), and ongoing review of SOPs.The Cosmetovigilance (CV), Pharmacovigilance (PV), and Medical Device Vigilance (MDV) Manager in Middle East countries (Saudi Arabia, UAE, Kuwait, Qatar, Oman, Bahrain, Iraq, Syria, Lebanon and Jordan) is responsible for ensuring, at a minimum, the following:Local Pharmacovigilance System Set UpCoordinate and organize, at the national/area level and in liaison with the Global Safety (GS), all activities in relation to the oversight on the safety profile of the portfolio.Local Qualified Person for Pharmacovigilance (QPPV)Act as the nominated person (or local QPPV) for the local competent authority if and as required by local regulations.Management of Pharmacovigilance (PV) CasesManage PV cases from all sources as per internal procedures.Collect, review, and follow-up on local ICSRs brought to the attention of the staff of Servier local structure or from other sources, and transmit the information to GS after analysis and completion.Collect, review, and follow-up on SADRs for named patient products (i.e., compassionate use) and transmit to GS.PSMF MaintenanceMaintain the Pharmacovigilance System Master File (PSMF) as applicable according to local regulatory requirements.Literature SurveillanceEnsure literature screening in local scientific journals and perform case processing for identified ICSRs as per internal procedures.Management of Key InterfacesEnsure oversight and periodic reconciliation on interfaces that are potential sources of PV cases.Study and Program OversightEnsure appropriate safety reporting processes are in place at the affiliate level and described in relevant local documents for global and local interventional and non-interventional studies and Compassionate Use according to Global processes and local regulatory authority requirements.Management of Aggregate ReportsProvide safety-related and country specific information to Global teams for the preparation of Aggregate Reports when necessary.Maintain an Aggregate Report tracking table with evidence of submission and compliance metrics.Ensure submission of Aggregate Reports (as applicable) to local regulatory authorities in accordance with global processes and local regulatory authority requirements.Oversight of Risk Management Plan (RMP) and Additional Risk Minimization Measures (RMM) ImplementationEnsure oversight of RMP implementation in collaboration with relevant staff in accordance with GS and local regulatory authority requirements.Follow up on the distribution of additional RMM locally and its compliance metrics.Submission of RMPs and aRMMs to Regulatory authority, when applicable. Signal DetectionEnsure local signal detection activities and communicate any potential local safety signals detected during routine pharmacovigilance activities to Global Safety.Oversee the signal evaluation report posted in the WRA Portal from Global Safety.Ensure country specific obligations (local appendix) are submitted.Safety Communication and Responses to National Competent Authority RequestsEnsure safety queries, other significant safety issues, and, if applicable, local/global crisis management are performed according to Global processes and local regulatory authority requirements.Maintain oversight of any safety communication to Healthcare Professionals or consumers as applicable.Provide the EEA-QPPV office with all relevant information to allow their oversight and follow up on requests from the EEA-QPPV office as applicable.Stay updated with local regulations.Labelling and CommitmentsEnsure awareness and contribute (as applicable) to local safety label updates in collaboration with Local Regulatory Affairs as applicable.Contribute to the implementation of commitments, when applicable.Pharmacovigilance Quality SystemImplement and maintain a local Pharmacovigilance Quality System in accordance with Global processes and local regulatory authorities requirements.Assume responsibility for educating and training relevant personnel in the affiliate and Business Partners or Service Providers, when applicable, and maintain local training records and compliance metrics.Conduct monthly reconciliation of product quality complaints, falsified medicinal products, and medical inquiries with local teams, business partners, service providers, and other external stakeholders to ensure all safety information is accurately captured.Local Pharmacovigilance AgreementParticipate in the negotiation and writing of local pharmacovigilance agreements with local partners or service providers.Inform the Global Safety International Unit beforehand on all contracts set up locally regarding pharmacovigilance activities and/or which have an impact on pharmacovigilance activities.Ensure compliance with agreements.Provide timely feedback to the Global Safety International Unit on all changes the LPV is aware of (e.g., change in products concerned by the pharmacovigilance agreement).Business ContinuityEnsure continuity of pharmacovigilance activities at the local level, including the setup of a system to cover out-of-business hours.Regulatory IntelligenceContinuously screen for updates of local legislation, perform impact analysis, and inform Global Safety of any changes.ArchivingEnsure that PV documents are archived in accordance with local regulatory requirements and data protection rules, as applicable.Audit and InspectionInform Global Safety as soon as a notification of an audit by a Business Partner or inspection is received and ensure the local contact point.Ensure the CAPA plan implementation within the defined timelines.The tasks listed above are not exhaustive, and additional tasks may be assigned based on business needs.Skills & KnowledgeEducational qualificationsDoctor of Pharmacy (PharmD)/ Pharmacy DegreeRelated PV training coursesRelevant Experience2- 3 Years experience as a Qualified Person Responsible for Pharmacovigilance (QPPV).Skills & Personal CharacteristicsDetail-oriented.Ability to prioritize tasks.Teamwork skills and adaptability to any type of environment.Development and maintenance of SOPs.Demonstrated capabilities in: Time management, Problem solving, and organization.Strong planning and presentation skills.Strong Communication Skills (English, Arabic).Proficiency in MS officeWhatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognised for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.