Job Description

Johnson & Johnson Innovative Medicine is recruiting for a Deputy Qualified Person for Pharmacovigilance (Deputy QPPV) & Local Medical Safety Specialist, acting as back up for the Local Safety Officer in Saudi Arabia. This role will work in a hybrid office/home model, based in our Riyadh office. Also, this role will collaborate with Gulf Local Medical Safety (LMS) team on defined projects/processes towards effective/efficient PV System implementation. As a pivotal member of our team, you will foster our dedication to patient safety and drug efficacy as the Deputy QPPV & Local Medical Safety Specialist. This dual role offers the outstanding opportunity to orchestrate our pharmacovigilance efforts within Saudi Arabia, ensuring our operations not only align with local regulations but also set industry standards for safety and efficacy. Key Responsibilities: Local Medical Safety Responsibility & Benefit Risk Management: Establish Product knowledge with a focus on safety profiles, Therapeutic Areas and Disease Pathway knowledge supporting the needs of the local operating company in collaboration with the Medical Safety Officer (MSO), the Country Safety team lead (CSTL), KSA LSO and other partners. Act as a safety expert in cross-functional team meetings and perform training on safety-relevant aspects, as appropriate. Provide Risk Management Plan (RMP) status updates, upon request, and support in the implementation of RMPs and Urgent Safety Restrictions, as needed. Participate in meetings with relevant partners (internally and externally) for discussion and evaluation of topics related to benefit-risk and product safety, as required. Contribute to the Gulf & KSA LMS strategy, by ensuring proactiveness, preparation of customized/ targeted safety messages to address business needs and ensure delivering regular and consistent safety updates for the products in scope.

Aggregate reports: Prepare the required medical input, insights and scheduling for aggregate reports while undertaking local review and ensure the submission of Periodic Safety Update Reports (PSURs/DSURs), as applicable. Signal Detection: Work with LSO KSA to ensure proper implementation of the local signal management process in alignment with the global standards and local regulations. Local Safety Communications Ensure timely and compliant safety submissions to the local health authorities, such as Significant Safety Issues. · Support QPPV KSA/LSO in addressing local Health Authority Queries compliantly and in timely manner. · Support in the preparation of the Saudi Specific Annex associated with new or updated Risk Management Plans, in collaboration with key stakeholders, as required by the local regulations. Business Continuity: Collaborate with Gulf LMS team to ensure adequate implementation and maintenance of local business continuity plans with a 24-hours system coverage. Pharmacovigilance-Safety training support: Prepare and deliver Pharmacovigilance trainings for internal teams and partners effectively and in timely manner. Work collaboratively with Gulf team on training materials/project/ initiatives that support elevating the level of knowledge on safety and increase the level of reporting. PV contract management: Support LSO KSA in managing the local Pharmacovigilance Agreements (PVAs) and ensure excellence in distributor operations, when required. Support LSO KSA in the preparation of third-party safety agreements, such as local Vendor Agreements, with assistance from central functions like PV Service and Technical Contracts Group, when required. Work collaboratively with Gulf LMS to review the compliance status and analyze the key performance indicators of distributor, and vendors, when required. Safety regulations: Support the review of new/revised safety regulations, evaluation of the impact on local processes, and notification to the appropriate global and regional groups. Local Safety compliance: Effectively implement the local Pharmacovigilance System Master File (PSMF) for KSA and PSMF Summary and ensure it remains updated regularly. Work collaboratively with Gulf LMS on the procedural document management to ensure accurate content and regular review. Work collaboratively with Gulf LMS in the preparation of the regional local compliance oversight, providing input, present topics and exchange learnings and best practices. Inspection/Audit Support CSTL/LSO KSA in driving the preparation for inspections/audits, addressing follow-up actions from findings, in collaboration with key stakeholders, when required. Experience and Skills: Saudi National, Pharmacist with minimum of 2 years of proven experience in the pharmaceutical industry, preferably in Pharmacovigilance. Scientific/ life-science background, medicinal knowledge preferred; proficiency in Medical terminology (local languages). Ability to manage multiple critical issues. Awareness of and familiarity with industry principles of drug development and pharmacology Good verbal and written communication skills, proficiency in local language(s) and English language required. Ability to communicate proactively and collaborate effectively with internal stakeholders. Be part of a team that values innovation and dedication. Here, your work in safeguarding patient safety and enhancing product efficacy is recognized and rewarded. Embrace the opportunity to grow professionally in a supportive, dynamic environment. Demonstrable knowledge of all local PV requirements and of Global aspects of drug safety. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit

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