Pharmacovigilance Lead Auditor
19 hours ago
ALK-Abello is seeking an experienced Lead Auditor with a passion for audits and pharmacovigilance. As a key member of the Global Quality function, you will work collaboratively with diverse cultures to contribute to making a difference for people with allergy.
Key Responsibilities:
- Performing pharmacovigilance audits independently or collaboratively with other PV and GDP Lead Auditors.
- Planning, execution, reporting, and CAPA follow-up.
- Supplier management, qualification of external collaborators, service providers, and distributors.
Requirements:
- Experience as Lead Auditor within pharmacovigilance, performing internal audits and external collaborator audits.
- Bachelor's or Master's degree in Health Science with 5+ years of experience in pharmacovigilance regulated areas.
- Quality management system and tool experience is essential.
- Previous audit experience in other GxP areas is advantageous.
Personal Qualities:
- Strong drive, initiative-taking, and proactive attitude.
- Ability to work independently and as part of a strong team.
- Relationship building skills with flexibility across cultures.
- Excellent verbal and written communication skills in Danish and English.
- Strong cross-cultural communication skills.
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