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Act as the Local Contact Person for Pharmacovigilance in Spain, available 24/7 for urgent safety issues. Ensure compliance with Spanish PV requirements, including local reporting obligations and maintenance of local PV documentation. Serve as the primary interface with Spanish health authorities (e.g., BfArM) for pharmacovigilance-related queries and inspections. Maintain awareness...
About the Role
Role Summary:
Serve as the designated Local Contact Person for Pharmacovigilance (LCPP) in Spain, ensuring compliance with Spanish and EU pharmacovigilance regulations. Act as the primary liaison with local health authorities and support the Qualified Person for Pharmacovigilance (QPPV) in maintaining the pharmacovigilance system. Additionally, lead global process ownership for assigned PV processes, driving standardization and continuous improvement across regions.
Key Responsibilities:
Local Pharmacovigilance Responsibilities (Spain):
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