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Patient Safety Lead
hace 2 meses
As a Patient Safety Lead, you will play a critical role in ensuring the safety of patients by managing pharmacovigilance activities in accordance with company requirements. You will partner with the PV Country Lead to ensure that systems and processes support regulatory compliance effectively.
Key Responsibilities- Manage pharmacovigilance activities, including ensuring compliance to all applicable global and local PV processes and regulations.
- Ensure audit/inspection readiness at all times.
- Support the development and implementation of necessary processes, systems, and tools for the handling of local PV activities.
- Support local and global PV strategies and implementation at the local operating company level.
- Act as a subject matter expert on pharmacovigilance-related matters, including regulatory requirements, resourcing, compliance, and other factors.
- Establish appropriate oversight of vendors/suppliers, as required.
- Monitor local Risk Management Plans (RMPs) and risk minimization activities relevant for the territory.
- Monitor or oversee Market Research (MR) and/or Patient Support Programs (PSPs) conducted at the local operating company to ensure safety information is managed appropriately.
- Review protocols for local studies and define PV-related processes for local study projects prior to their initiation, in order to ensure compliance with pharmacovigilance requirements and company standards.
- Work with global PV colleagues and the EU QPPV office as applicable to implement any strategies related to EU and local/regional requirements.
- Engage with key local internal stakeholders, including Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial teams, and external stakeholders with PV obligations, agreements, etc.
- Health professional or life sciences degree (Bachelor's required; advanced degree preferred).
- Minimum of 5 years' advanced experience in pharmacovigilance or related environments, with adjustments based on country/regional requirements.
- Advanced experience of working cross-functionally, preferably in RD companies.