Patient Safety Lead - Pharmacovigilance

About the role

The Patient Safety Lead will drive the local patient safety strategy and ensure a robust, compliant Pharmacovigilance (PV) system. Acting as the primary contact for health authorities and internal stakeholders, you will transform PV from a reporting function into a strategic, patient‑centric capability.

Key responsibilities

• Maintain holistic oversight of local PV compliance and inspection readiness.
• Serve as the single point of contact or Qualified Person for Pharmacovigilance (QPPV) for health authorities and internal networks.
• Oversee execution of safety activities including Individual Case Safety Reports (ICSRs), signal management, aggregate reporting, PVAs, risk minimisation measures (aRMM) and safety labeling.
• Integrate the patient safety strategy with therapeutic area goals, partnering with Medical, Access and other cross‑functional teams.
• Engage external stakeholders, industry associations and healthcare organisations to shape a safer regulatory environment.
• Provide strategic input on product launches, real‑world evidence generation, safe home treatment and health technology assessments.
• Coach and empower local Patient Safety Partners, fostering a continuous‑learning culture and appropriate resource allocation.
• Connect local priorities with global Safety NET and regional hubs to scale high‑impact initiatives.

Required profile

• University degree in Medicine, Pharmacy, Healthcare or a PhD/Master’s in Life Sciences/Public Health meeting local QPPV qualification standards.
• 3‑5+ years of Pharmacovigilance experience in an affiliate setting; experience in Medical Affairs or Clinical Development is a plus.
• Deep knowledge of local and global PV regulations, risk management and system oversight.
• Strategic mindset, customer‑centric approach and proven cross‑functional leadership under the VACC model (Visionary, Architect, Coach, Catalyst).
• Fluent English and Spanish, with a digital‑first attitude to leverage regional resources.

Required skills

• Pharmacovigilance regulations and compliance
• Signal detection and management
• Risk minimisation measures (aRMM)
• Aggregate safety reporting
• Safety labeling processes