18 sep
|
Novartis
|
Barcelona
18 sep
Novartis
Barcelona
Salary Range:
€69,100.00 - €128,300.00
Job Description Summary What if your expertise could help strengthen the systems that protect millions of patients around the world?
Job Description Location: Barcelona, Spain
LI-Hybrid
Relocation Support: This role is based in Barcelona, Spain. Novartis is unable to offer relocation support, please only apply if accessible.
Major Accountabilities Lead quality oversight of global Pharmacovigilance and Device Vigilance activities to ensure regulatory compliance.
Drive quality improvement initiatives that strengthen compliance, efficiency, and operational excellence.
Identify compliance risks and provide mitigation recommendations to Patient Safety stakeholders.
Support due diligence activities for product acquisitions and business development opportunities.
Lead quality activities supporting mergers, acquisitions, divestments, and system integrations.
Support maintenance of the Pharmacovigilance System Master File and related quality systems.
Guide complex investigations, corrective actions, and preventive action plans to resolution.
Support health authority inspections, inspection readiness activities, and remediation efforts.
Provide quality governance and oversight for global pharmacovigilance operational vendors.
Deputize for the Team Head, providing leadership support and ensuring continuity of critical quality activities.
Essential Requirements Degree in Life Sciences or a related scientific discipline.
Excellent written and verbal communication skills in English.
Fluency in at least one additional language.
Significant experience in pharmacovigilance quality, pharmacovigilance operations, or pharmaceutical compliance.
Strong knowledge of general pharmacovigilance regulations, guidelines, and quality requirements.
Proven ability to manage complex compliance issues and drive effective resolutions.
Demonstrated leadership skills with success in cross‐functional and global environments.
Quality‐focused mindset with strong prob
📌 Associate Director, Pharmacovigilance QA (Barcelona)
🏢 Novartis
📍 Barcelona