Join our client in Braine-l'Alleud as a Global Pharmacovigilance quality lead to champion excellence in global healthcare quality systems through strategic leadership and hybrid collaboration. This role offers the chance to drive a culture of shared accountability while ensuring compliance across life-changing research and development processes. You will balance operational output with regulatory requirements to deliver sustainable access for patients worldwide.
Key Responsibilities
Strategic PV Leadership : lead medium to high complexity projects to ensure the effectiveness of global Pharmacovigilance Quality Management Systems (QMS).
Regulatory Expertise : deliver expert guidance on Global Pharmacovigilance Practices (GVP) and GCP regulatory expectations (FDA, EMA, ICH) and industry best practices.
Inspection Management : lead the hosting of PV audits and Health Authority inspections, developing and implementing effective remediation plans for findings.
Compliance Monitoring : oversee the on-time delivery of critical PV outputs, including ICSSrs, aggregate reports (DSURs), Risk Management Plans (RMPs), and REMS.
Vendor & Partner Oversight : ensure quality oversight and data integrity for PV activities delegated to external vendors and partners.
Risk & Deviation Management : initiate deviations, conduct root cause analysis, and track the effectiveness of CAPA implementation.
Qualifications
You bring 8 to 10 years of specialized experience in drug safety/pharmacovigilance quality assurance within the pharmaceutical industry.
You possess a deep understanding of quality management systems within an international and transversal environment.
Your background includes a strong internal and external network related to GCP and GVP standards.
You demonstrate excellent verbal and written communication skills in English to engage with global stakeholders.
Your professional experience shows a proven ability to lead complex projects and influence organizational quality culture.
Experience a modern hybrid work model that offers the perfect balance between office collaboration and home-based focus.
Contribute to a mission-driven organization dedicated to delivering innovative solutions and sustainable patient access.
Work a full-time schedule of 40 hours per week within a professional and approachable team environment.
Ready to make a global impact on healthcare quality? We are looking forward to meeting you, so take the next step in your career and apply today!
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