Patient Safety Partner/ Qualified Person for PharmacoVigilance Back-Up
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Key skills for this role
About the Role
Roche seeks a Patient Safety Partner to support the local PV system in Saudi Arabia, acting as QPPV Deputy. Responsibilities include executing safety activities, ensuring compliance with global and local requirements, and contributing to risk management.
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
- Ensure adherence to global Roche requirements and local regulatory authority requirements
- Handle Individual Case Safety Reports, Signal Detection & Signal Management for Local Products
- Manage Aggregate safety reports, Pharmacovigilance Agreements, Risk Management and Safety Communication
- Contribute to shaping country PV regulations and the broader pharmacovigilance ecosystem
- Support risk management and safety communication, including DHPCs
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
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).
- You will ensure an efficient and effective PV system that complies with global Roche and local legal/regulatory authority PV requirements, safeguarding our License to Operate.
- Support the execution of Affiliate’s Patient Safety (APS) strategies, ensuring high quality implementation of global and local safety solutions.
Your Responsibilities
- Act as the Local QPPV Deputy in Saudi Arabia, responsible for execution of safety related activities relevant to the PV system.
- Ensure adherence to global Roche requirements and local regulatory authority requirements.
- Handle Individual Case Safety Reports, Signal Detection & Signal Management for Local Products.
- Manage Aggregate safety reports, Pharmacovigilance Agreements (PVA, SDEAs), Risk Management and Safety Communication.
- Contribute to shaping country PV regulations and the broader pharmacovigilance ecosystem.
- Collaborate and support in the implementation of safety solutions and launch readiness activities.
- Support risk management and safety communication, including DHPCs.
Who you are?
- 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.
- Advantage: Experience in other affiliate medical functions or global functions such as Clinical Safety.
- A Saudi national is preferred.
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