Pharmacovigilance Audit Programme Lead

hace 3 semanas

Madrid Centro, Madrid, España Johnson & Johnson A tiempo completo
About This Role

We are seeking a highly skilled and experienced Pharmacovigilance Audit Programme Lead to join our team at Johnson & Johnson. As a key member of our Pharmacovigilance team, you will be responsible for leading the planning, conduct, and reporting of audits to ensure adherence to corporate policies, internal standards, and regulatory requirements.

Key Responsibilities
  1. Audit Strategy and Auditing: Collaborate with cross-functional teams to develop and execute audit strategies that enhance the effectiveness and sustainability of the audit program, while ensuring compliance with global regulatory expectations.
  2. Independent Auditing: Lead the planning, conduct, and reporting of routine and non-routine audits to ensure adherence to corporate policies, internal standards, and regulatory requirements.
  3. Complex Audit Management: Manage complex or business-critical audits/issues in a supporting or leading role, providing expert input to risk management strategies and translating them into audit plans and scopes.
  4. Audit Risk Prioritization: Manage and maintain audit risk prioritization tools, review risk profiles, and provide expert input to risk management strategies.
  5. Data Analytics: Leverage data analytics tools to analyze relevant data sources, evaluate and analyze data to identify trends and insights, and provide input for the development of the audit program.
  6. Continuous Improvement: Support continuous improvement in audit methodologies, advance and enable risk-based auditing as a routine way of working, and work with business partners to develop and align QA compliance positions.
  7. Inspection Support: Provide support for regulatory inspection activities commensurate with expertise.
  8. Training and Development: Support training and development strategies for team members to support PV compliance activities, collaborate with cross-functional teams to ensure required skills are available to execute cross-sector PV audits.
  9. Project Management: Take an active role in and lead projects and teams in key project initiatives across the organization, influencing stakeholders and determining priorities, checkpoints, and timelines for all aspects of work and projects.
  10. Program Expertise: Maintain expert-level knowledge of Pharmacovigilance and PV-related IT knowledge, providing critical information, advice, and guidance on complex quality and compliance issues, and serving as a primary contact for internal and external stakeholders.
Requirements

To be successful in this role, you will need to have a strong background in Pharmacovigilance, audit experience, and excellent communication and project management skills. You will also need to be able to work independently and collaboratively as part of a team, and have a strong attention to detail and ability to analyze complex data.

What We Offer

As a member of our team, you will have the opportunity to work on challenging projects, develop your skills and expertise, and contribute to the success of our organization. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

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