Patient Safety Partner/ Qualified Person for PharmacoVigilance Back-Up
Job Fit Check
Base Career helps you apply smarter for this job.
Key skills for this role
About the Role
Roche is seeking a Patient Safety Partner / QPPV Deputy in Saudi Arabia to support the local pharmacovigilance system, ensuring compliance with global and local regulatory requirements.
Key Skills for This Role
Responsibilities
- Act as the Local QPPV Deputy in Saudi Arabia, responsible for execution of safety related activities relevant to the PV system
- Support implementation, maintenance and oversight of the local PV system to ensure compliance with global Roche and local regulatory requirements
- Handle Individual Case Safety Reports, Signal Detection & Signal Management for Local Products, Aggregate safety reports, Pharmacovigilance Agreements, Risk Management and Safety Communication
- Contribute to shaping country PV regulations and the broader country pharmacovigilance ecosystem as applicable
- Collaborate and support implementation of safety solutions and launch readiness activities to address patient safety risk management needs
- Support risk management and safety communication, including DHPCs, to relevant external stakeholders
Requirements
- Degree in healthcare related discipline (e.g., PharmD, Pharmacy)
- Licensed pharmacist by the Saudi Commission for Health Specialties
- 1 3 years experience in pharmacovigilance, ideally in an affiliate setting
- Understanding of decision making in the local & global PV ecosystem
- Saudi national is preferred
Full Job Posting
The Opportunity
- As a Patient Safety Partner, you will be responsible for supporting the implementation, maintenance and oversight of the local PV system for the assigned affiliate(s)/country(ies), to ensure an efficient and effective PV system that complies with global Roche and local legal/regulatory authority PV
- You will also support the execution of Affiliate’s Patient Safety (APS) strategies, ensuring high quality implementation of global and local safety solutions, while demonstrating leadership in ownership, collaboration, and decision making within assigned responsibilities.
Your Responsibilities: PV System
- Act as the Local QPPV Deputy in Saudi Arabia, and be responsible for the execution of safety related activities relevant to the PV system through partnership with key stakeholders guaranteeing adherence to global Roche requirements and requirements mandated by the local Regulatory Authority.
- Key areas include: Individual Case Safety Reports, Signal Detection & Signal Management for Local Products, Aggregate safety reports, Pharmacovigilance Agreements (PVA, SDEAs), Risk Management and Safety Communication, Studies, Programs and other projects with PV implications, Safety Labeling and PV
- Contribute to shaping country PV regulations and the broader country pharmacovigilance ecosystem as applicable.
Local Safety Risk Management
- Collaborate and support in the implementation of safety solutions and launch readiness activities to ensure that patient safety risk management needs are addressed for Roche portfolio in the country.
- As applicable, support in identifying and sharing safety insights by understanding disease areas and engaging with key stakeholders.
- Support risk management and safety communication: Support the country level risk management strategy to optimize patient outcomes in collaboration within relevant networks and ensure compliant and transparent PV communications (e.g., DHPCs) to relevant external stakeholders.
Who you are?
- Degree in healthcare related discipline (e.g., PharmD, Pharmacy, etc.).
- Licensed pharmacist by the Saudi Commission for Health Specialties.
- 1 3 years experience in pharmacovigilance, ideally in an affiliate setting.
- Understanding of decision making in the local & global PV ecosystem.
- Advantage: Experience in other affiliate medical functions (e.g., Medical Affairs, Clinical Operations, Medical Information) or global functions such as Clinical Safety.
- A Saudi national is preferred.
Apply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
More jobs at Roche
Healthcare Systems Partner
Riyadh, KSA
Roche is seeking a Healthcare System Partner to collaborate with healthcare stakeholders, identify common goals, and co-create solutions to improve patient outcomes. The role requires experience in Market Access and a de
Healthcare Systems Partner
الرياض, KSA
Roche seeks a Healthcare System Partner to collaborate with healthcare stakeholders in Saudi Arabia, identifying common goals and co-creating solutions to improve health outcomes. The role requires a university degree in
Supply Chain and Operational Effectiveness Lead
Laval, CAN
Roche Diagnostics Canada seeks a Supply Chain and Operational Effectiveness Lead to orchestrate the order-to-delivery lifecycle, drive digital automation and AI/ERP automation, and lead teams in customer service, logisti
Business Analyst in Global Clinical Supply Chain Planning
Mississauga, CAN
Roche seeks a Clinical Supply Chain Business Analyst to build and own reporting and analytics capabilities within the Clinical Supply Chain Planning domain. The role involves translating business requirements into analyt
Business Analyst in Global Clinical Supply Chain Planning
Mississauga, CAN
Roche is seeking a Clinical Supply Chain Business Analyst to build reporting and analytics capabilities for global clinical supply chain planning. You will translate business requirements into analytical solutions, drive
Regional Capability Lead
Saudi Arabia, KSA
Drive capability strategy and lead regional transformation while designing impactful learning experiences; requires expertise in learning development and change management.
Regional Capability Lead for Middle East
Riyadh, KSA
Roche seeks a Regional Capability Lead for the Middle East to shape healthcare capabilities. The role combines strategic vision with operational excellence to establish and scale core commercialization capabilities, empo
Regional Capability Lead for Middle East
Riyadh, KSA
Roche is seeking a Commercial Capability Development Lead to shape healthcare capabilities across the Middle East. The role involves driving capability strategy, leading regional transformation, designing impactful learn
Healthcare Systems Partner
Riyadh, KSA
Healthcare Systems Partner
الرياض, KSA
Supply Chain and Operational Effectiveness Lead
Laval, CAN
Business Analyst in Global Clinical Supply Chain Planning
Mississauga, CAN
Business Analyst in Global Clinical Supply Chain Planning
Mississauga, CAN
Regional Capability Lead
Saudi Arabia, KSA
Regional Capability Lead for Middle East
Riyadh, KSA
Regional Capability Lead for Middle East
Riyadh, KSA