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.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.