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Novartis

Global pharmaceutical company delivering science-based innovations

Global Head External Vigilance Engagements

Regulatory & Quality (Life Sciences)Posted on Nov 12
Full-timeBarcelona, Spain

About the Job

Requirements

  • A degree in Biomedical Science or a related scientific discipline is required.
  • At least eight years of experience in clinical safety, pharmacovigilance, regulatory, or compliance-related areas is required.
  • Current knowledge of global pharmacovigilance or device vigilance regulations and guidelines is required.
  • A strong understanding of clinical safety reporting requirements and clinical safety database environments is required.
  • Proven experience building and leading complex, international, and multidisciplinary teams within matrix organizations is required.
  • Strategic thinking, decision-making, negotiation, and problem-solving capabilities are required.
  • The role requires influencing and communication skills and confidence engaging senior internal and external stakeholders.
  • Fluent written and spoken English is required, with the ability to work effectively across diverse cultures and global teams.

Responsibilities

  • Lead and provide operational oversight of the global External Vigilance Engagements team and outsourced operations.
  • Shape strategy for external vigilance engagements, including incoming and outgoing assets and partnership transitions.
  • Oversee negotiation, implementation, and ongoing management of global vigilance agreements and external partnerships.
  • Provide expert guidance on pharmacovigilance and device vigilance requirements for complex contractual arrangements.
  • Identify compliance risks and ensure effective corrective actions with internal functions and external business partners.
  • Represent Patient Safety and Pharmacovigilance in strategic business forums, collaborations, and external engagements.
  • Maintain expertise in evolving global pharmacovigilance and device vigilance regulations, standards, and guidelines.
  • Drive inspection and audit readiness by supporting risk assessments, partner audits, and regulatory inspections.
  • Lead training and communication on global standards and procedures governing External Vigilance Engagements.
  • Build team capabilities and foster effective collaboration across complex global, cross-functional, and external partnerships.

Desired Qualifications

  • A higher degree in Biomedical Science or a related scientific discipline is desirable.
  • Knowledge of languages beyond English is desirable.

About the Company

Novartis

Global pharmaceutical company delivering science-based innovations

Novartis is a global pharmaceutical company that uses science-based innovations to develop treatments and improve patient outcomes worldwide. Its products are medicines developed through research and development to address various diseases, aiming to reach nearly 1 billion people. The company differentiates itself by large-scale investment in R&D, a global presence with a diverse workforce, and a clear mission to Reimagine Medicine, focusing on meeting the changing needs of patients. Its goal is to improve quality of life and extend life expectancy by delivering meaningful therapies through its research and development efforts.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1970

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