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We are seeking a highly skilled and experienced Senior Manager to lead our Pharmacovigilance Audit Program. As a key member of our team, you will be responsible for shaping and executing audit strategies to ensure compliance with global regulatory requirements.
Key Responsibilities- Audit Strategy and Compliance: Develop and implement audit strategies to enhance the effectiveness and sustainability of our audit program. Lead the planning, conduct, and reporting of routine and non-routine audits to ensure adherence to corporate policies and regulatory requirements.
- Inspection Support: Provide expert support for regulatory inspection activities.
- Training and Development: Collaborate with our team to develop training strategies and support talent development and training.
- People Management: Deputize for the Director, PV Audit Strategy Lead when requested.
- Project Management: Lead projects and teams in key initiatives across the organization.
- Program Expertise: Maintain expert-level knowledge of Pharmacovigilance and PV-related IT systems.
- A minimum of a bachelor's degree is required; an advanced degree is preferred.
- A minimum of 8 years of experience in the pharmaceutical/biotech industry is required.
- Pharmacovigilance Quality and Compliance experience is required.
- Knowledge of Pharmacovigilance and/or QMS audit is required.
- Audit strategy experience is preferred.
