Country Patient Safety Head, Spain

Key Responsibilities:

• Provide strategic leadership in collaboration with regional heads to meet regulatory and organizational goals in complex, high-visibility countries.
• Act as the single point of contact for local health authorities on pharmacovigilance (PV) and device vigilance matters, available 24/7.
• Serve as Country Patient Safety Head (CPSH) for all Novartis divisions, with documented delegation to deputies if applicable.
• Oversee the local PV system, ensuring compliance in case processing, reporting, training, licensing, safety studies, and digital initiatives.
• Maintain access to all relevant documentation to monitor PV system structure and performance.
• Monitor internal and external compliance, investigate delays, and implement corrective/preventive actions for safety reporting.
• Manage third-party PV vendors, ensuring performance and compliance through collaboration with QA and vendor management.
• Lead regulatory intelligence efforts, assessing impact of new legislation and advising global PS teams on local implications.
• Ensure compliance with local legislation, aligning Novartis systems and tools with national requirements.
• Respond to health authority requests in coordination with Regulatory Affairs and global safety teams.
• Manage audits and inspections, supporting corrective actions and contributing as a PV subject matter expert.
• Engage in the QPPV-CPSH network, monitoring emerging safety concerns and supporting urgent regulatory actions.
• Oversee Patient Oriented Programs (POPs) locally, ensuring governance and compliance with regulations and internal procedures.

Essential Requirements:

• Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist) or equivalent education, training and experience Proficiency in English & Spanish required – spoken & written.
• Significant experience in drug-safety or pharmacovigilance (preferred) and/ or experience in pharmaceutical industry
• Relevant demonstrated leadership experience and accomplishment in all aspects of patient safety in a local/matrix environment in the pharmaceutical industry
• Extensive knowledge of regional and local requirements relating to PV - ability to solve complex regulatory issues and requirements
• Working knowledge of PV-processes, covering compliance, databases, procedures, QA, training. Proven ability to critically evaluate and integrate data from a broad range of areas/domains.
• Experience in PV audits and inspections
• Ability to effectively communicate with different stakeholders; Demonstrated track record to successfully lead/work in interdisciplinary global teams; leading, planning, and prioritizing activities simultaneously on multiple projects
• Experienced leader in a matrix organization, including ability to influence and provide guidance and direction to team members - Demonstrated ability for innovative and big picture thinking
• Strong planning, negotiation, organizational and interpersonal skills
• Computer/IT systems literacy

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.