QPPV & LOCAL SAFETY OFFICER KSA

The Johnson & Johnson Family of Companies A global leader in health and personal care, with over employees in over 275 companies in 60 countries.
We work with healthcare partners to touch the lives of more than a billion people every day worldwide.
“By caring, one person at a time, we aspire to help billions of people live longer, healthier, happier lives.” Johnson & Johnson Innovative Medicine is recruiting for a QPPV & Local Safety Officer in Saudi Arabia.
This role will work in a hybrid office/home model based in our Riyadh office.
As a pivotal member of our team, you will foster our dedication to patient safety and drug efficacy as the Qualified Person for Pharmacovigilance (QPPV) and Local Safety Officer.
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 International Medical Safety Officer (MSO) the Country Safety team lead (CSTL), 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 for discussion and evaluation of topics related to benefit-risk and product safety, as required.
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.
Signal Detection.
Ensure adequate local signal detection process in alignment with the global standards and local regulations.
Local Safety Communications Ensure timely and compliant safety submissions and to the local health authorities and Health Care Professionals (HCP).
Business Continuity.
Ensure accurate implementation and maintenance of local business continuity plans with a 24-hours system coverage.
Pharmacovigilance-Safety training support.
Lead Pharmacovigilance training for internal teams and partners effectively and in timely manner.
PV contract management.
Ensure accurate oversight of the local Pharmacovigilance Agreements (PVAs), including Local Safety Unit (LSU) training and adherence to PVAs; Supervise support for vital third-party safety agreements locally, such as local Vendor Agreements, with assistance from central functions like PV Service and Technical Contracts Group.
Safety regulations.
Stay updated on regulations, ensuring our practices are ahead of the curve.
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.
Implement effectively the local Pharmacovigilance System Master File (PSMF), ensure compliance oversight on the procedural document management, and provide insights into metrics to the CSTL, when needed.
Inspection/Audit.
Support CSTL in driving the preparation for inspections/audits, addressing follow-up actions from findings, when required Qualifications Experience and Skills.
Saudi National, Pharmacist with minimum of four years of proven experience in the pharmaceutical industry, preferably in Pharmacovigilance or Medical Affairs.
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 effectively with internal and external customers.
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 www.
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