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):
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 of local regulatory changes and implement necessary updates to PV processes.Support the EU QPPV in oversight of the PV system and ensure alignment with the Pharmacovigilance System Master File (PSMF).Additional Responsibilities:
Prepare and maintain PSMFs and local annexes for Spain.Oversee development and negotiation of pharmacovigilance agreements for assigned clients.Act as EU QPPV for small clients, where applicable.Mentor and train team members on PV processes and regulatory requirements.Support audits and inspections at global and local levels.Qualifications:
Education: Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related field (advanced degree preferred).Experience:Minimum 5 years in pharmacovigilance or drug safety within a pharmaceutical company or CRO.At least 3 years of experience in PV system management and regulatory compliance.Previous experience as LCPP or similar role in Spain strongly preferred.Knowledge:In-depth understanding of EU and Spanish PV regulations (GVP Modules, AMG requirements).Strong knowledge of PV agreements, PSMF, and risk management processes.Skills:Excellent communication skills in English and Spanish (written and verbal).Strong organizational and time management skills; ability to manage multiple priorities.Effective stakeholder management and relationship-building skills.Ability to lead process improvement initiatives globally.Additional Requirements:
Availability for 24/7 contact as required by Spanish PV regulations.IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com.
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