Country Patient Safety Head, Spain

Band

Level 6

 

Job Description Summary

In collaboration with global and local leadership, the Country Patient Safety Head (CPSH) leads the development and execution of patient safety strategy and operational excellence at the national level, ensuring compliance with all relevant regulations and corporate standards for both marketed and investigational products. In a large country with high regulatory demands, the CPSH oversees the local patient safety department and quality management system, working closely with Quality Assurance. As a senior leader, influence global and local pharmacovigilance strategies to ensure alignment and consistency, while also supporting talent development by mentoring less experienced safety associates.

#Hybrid
Location: Barcelona, Spain

 

Job Description

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.

 

Skills Desired

Clinical Research, Clinical Trials, Regulatory Compliance, Safety Science, Team Management