Patient Safety Lead, Qualified Person for Pharmacovigilance
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Key skills for this role
About the Role
Roche is seeking a Patient Safety Partner to support the implementation and oversight of the local pharmacovigilance (PV) system for the assigned affiliate. The role involves ensuring compliance with global and local PV requirements, managing safety data, and contributing to risk management strategies.
Key Skills for This Role
Responsibilities
- Support the implementation, maintenance and oversight of the local PV system
- Act as the Local QPPV Deputy in Saudi Arabia
- Execute safety related activities including Individual Case Safety Reports, Signal Detection, Aggregate safety reports, and Pharmacovigilance Agreements
- Contribute to shaping country PV regulations
- Support risk management and safety communication
Requirements
- Experience in pharmacovigilance
- Knowledge of local and global PV regulations
- Ability to act as Local QPPV Deputy
- Experience with safety risk management
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.
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 Authori
- Key areas of activities include: Individual Case Safety Reports, Signal Detection & Signal Management for Local Products, Aggregate safety reports, Pharmacovigilance Agreements (PVA, SDEAs), Risk Management and Safety Communication, Safety Labeling and PV Commitments and (Local) Pharmacovigilance Sy
- 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.
- 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.
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