About this role

Prepare activity monitoring dashboards and perform trend analyses for internal reviews
Participate in partner risk analyses with the SDEA team to contribute to audit planning
Prepare audits in coordination with the external provider contracted to conduct them
Serve as the liaison between internal teams, the audit provider and partners throughout the process (pre-audit, audit, post-audit)
Review audit reports prior to finalization and ensure entry and tracking of CAPAs in the quality database until closure
Manage other partner quality monitoring activities, including sending and analyzing pharmacovigilance assessment questionnaires

Advanced scientific degree (pharmacy, life sciences, quality, clinical, etc.)
Proven experience in pharmacovigilance, quality assurance or audit management within the pharmaceutical industry
Strong knowledge of pharmacovigilance systems and regulations (European and international)
Demonstrated skills in quality management, audits, CAPA and quality systems
Proficiency in data analysis for dashboard creation and trend analysis
Professional English (frequent interactions with international partners)

Consultant – Partner Quality and Pharmacovigilance Audits

Key skills