WEU PV Leader & UK Safety Head (Hybrid)

Opella Healthcare Group; Reading; Ibrido; GBP 90.000 - 120.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work model

Descrizione del lavoro

Opella is seeking an experienced PV Zone Lead WEU & Country Safety Head UK to provide strategic and operational leadership for pharmacovigilance across the UK, Spain, Portugal, and Greece/Cyprus. Based in Reading with hybrid work, you will lead the safe and compliant PV system, interacting with health authorities and the QPPV organisation.

You will oversee local safety surveillance, case management, risk management plans, and audits, while building partnerships with Medical, Regulatory, Quality,

Competenze

• Extensive pharmacovigilance experience across EU regions.
• Experience with Health Authority interactions, inspections and regulatory expectations.
• Strong leadership and cross-functional collaboration across functions.
• Knowledge of GVP requirements and safety governance.
• Vendor management and multi-country safety activities experience.

Mansioni

• Lead Pharmacovigilance Operations across WEU & UK, ensuring compliance with global standards.
• Act as Primary PV Contact for Health Authorities and support inspections/regulatory interactions.
• Oversee Local Safety Surveillance: case management, signal management, literature monitoring, and RMPs.
• Drive PV Quality & Compliance: maintain PV systems, training, CAPAs and audit readiness.
• Collaborate with Medical, Regulatory, Quality, Legal, Commercial and Country Leadership teams.

Conoscenze

Pharmacovigilance

Leadership

Stakeholder Engagement

Regulatory Compliance

Inspection Readiness

Formazione

Advanced Degree in Life Sciences, Pharmacy, Medicine, Dentistry, or related discipline

Strumenti

PV Systems

Safety Databases

Descrizione del lavoro

Opella is seeking an experienced PV Zone Lead WEU & Country Safety Head UK to provide strategic and operational leadership for pharmacovigilance across the UK, Spain, Portugal, and Greece/Cyprus. Based in Reading with hybrid work, you will lead the safe and compliant PV system, interacting with health authorities and the QPPV organisation.

You will oversee local safety surveillance, case management, risk management plans, and audits, while building partnerships with Medical, Regulatory, Quality,