Patient Safety Partner/ Qualified Person for PharmacoVigilance Back-Up

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 requirements, safeguarding our License to Operate. 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 (Pharmacovigilance) system through partnership with key stakeholders guaranteeing adherence to global Roche requirements and requirements mandated by the local Regulatory Authority. 

Key areas of activities include the following in line with Roche standard operating procedures (where applicable): 

Individual Case Safety Reports, Signal Detection & Signal Management for Local Products, Aggregate safety reports, Pharmacovigilance Agreements (PVA, SDEAs), Risk Management and Safety Communication (e.g., Direct Healthcare Professional Communication, Risk Minimization Measures, emerging safety issues), Studies, Programs and other projects with PV implications, Safety Labeling and PV Commitments and (Local) Pharmacovigilance System Master File

• 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