Patient Safety Partner/ Qualified Person for PharmacoVigilance Back-Up

Overview

The Opportunity

**Your Responsibilities:****PV System:**

• Act as the Local QPPVDeputyin 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 asapplicable.

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
• Wer wir sind
• Eine gesündere Zukunft treibt uns zur Innovation an.
• Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen.
• Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt.
• Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
• Gemeinsam können wir eine gesündere Zukunft gestalten.
• Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.