Patient Safety Lead
Posted on :
07-03-2024
Employer Active
1 Vacancy
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Job Description
Req ID : 2595741
- Maintain holistic and comprehensive oversight of local Pharmacovigilance (PV) compliance, including inspection readiness and act as the single point of contact for Safety, internally and externally, for safety-related aspects or as Qualified Person for Pharmacovigilance (QPPV), or similar, where required by the local regulatory authority
- Contribute to the efficient, high-quality operational execution of Safety-related activities relevant to the PV system in partnership with the Pharmacovigilance Hub(s) to ensure monitoring of the safety profile of Roche products and their safety risk management, meet regulatory requirements, and ensure license to operate
- Ensure the implementation of Roche Safety Vigilance in the Affiliate and drive mindset and behaviors to advance PV customer centricity and value for patients
- Proactive safety expert support as a thought partner for patient-centric activities and projects, including product launches, precision medicine and other strategic affiliate activities (e.g., Safety data and insights, safety risk management, adequate PV oversight on local data generation and RWE activities)
- Act as a trusted point of contact for Global Safety, the network, the Hub and be the point of contact for Patient Journey Partners (PJPs)/Health System Partners (HSPs) and local colleagues for safety expertise (e.g., co-create and have oversight of PV safety communication to external stakeholders including the communication of the right safety information to the right audience at the right time through the right channel in a transparent manner to address the identified and emerging needs of patients and HCPs through primary points-of-contact and channels)
- Drive the local Patient Safety strategy working in close collaboration with the other functions (e.g. Medical, Access, PJP/HSP etc) as part of the integrated disease area or therapeutic area strategy and set priorities based on local business needs, customer expectations, portfolio/ disease area focus
- Ensure business continuity and collaborates with line management, cross-country network on resource activities to ensure appropriate prioritization and resource allocation to deliver key focus areas and outcomes, and provide feedback to ensure the right skills and expertise are deployed to the team
Employment Type
Full Time
Department / Functional Area
Doctor / Nurse / Paramedics / Hospital Technicians / Medical Research
Key Skills
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