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Pharmacovigilance Audit Strategy and Compliance Manager

hace 2 meses

Zaragoza, Zaragoza, España Importante empresa A tiempo completo
About the Role

We are seeking a highly skilled and experienced professional to join our team as a Senior Manager, Pharmacovigilance Audit Program Lead. This is an exciting opportunity to work with a leading company in the pharmaceutical industry, driving quality and compliance initiatives.

Key Responsibilities
  1. Audit Strategy and Compliance: Develop and implement effective audit strategies to ensure compliance with regulatory requirements and corporate policies. Lead the planning, conduct, and reporting of audits to ensure adherence to quality standards.
  2. Inspection Support: Provide expert support for regulatory inspection activities, ensuring seamless execution and minimal disruption to business operations.
  3. Training and Development: Design and deliver training programs to enhance the skills and knowledge of team members, ensuring they are equipped to execute PV compliance activities effectively.
  4. People Management: Collaborate with the leadership team to develop and implement strategies for talent development and succession planning.
  5. Project Management: Lead cross-functional projects, influencing stakeholders and determining priorities, checkpoints, and timelines to ensure successful project delivery.
  6. Program Expertise: Maintain in-depth knowledge of Pharmacovigilance and PV-related IT systems, providing critical guidance on complex quality and compliance issues.
Requirements
  1. A minimum of a bachelor's degree in a relevant field is required; an advanced degree is preferred.
  2. A minimum of 8 years of experience in the pharmaceutical/biotech industry is required.
  3. Pharmacovigilance Quality and Compliance experience is essential.
  4. Knowledge of Pharmacovigilance and/or QMS audit is required.
  5. Audit strategy experience is highly desirable.