Senior Pharmacovigilance Quality & Compliance Lead (AD Level)

Planet Pharma; Zürich; Vor Ort; CHF 170.000 - 210.000; Vollzeit

Zusammenfassung

Planet Pharma is seeking a Senior Pharmacovigilance Quality & Compliance Lead (AD Level) to shape and manage the global PV Quality Management System from Zürich. You will drive audit readiness, PV agreements, training programs, and process improvements while partnering with Safety, Quality, Regulatory and external partners.

The role offers visibility across the organization with opportunities to influence global teams and improve patient safety standards.

Qualifikationen

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Healthcare, or related scientific field.
• 10+ years of pharmaceutical or biotech experience.
• 5+ years in Pharmacovigilance / Drug Safety.
• Proven experience managing or developing PV Quality Management Systems.
• Strong experience supporting regulatory inspections and audits globally.
• Knowledge of global PV regulations including Europe, US, and Japan.
• Experience with CAPAs, deviations, procedural documents, and compliance monitoring.
• Excellent leadership, communication, and stakeholder management skills.

Aufgaben

• Lead and enhance the global Pharmacovigilance Quality Management System.
• Drive continuous improvement initiatives, issue management, CAPAs, and KPI development.
• Ensure compliance with global PV regulations and quality standards.
• Coordinate and support global pharmacovigilance audits and regulatory inspections.
• Lead inspection preparedness activities and support audit responses.
• Manage findings, corrective actions, and compliance remediation plans.
• Develop and manage global pharmacovigilance training programs.
• Oversee SOP, procedural document, and document control activities.
• Deliver training and support inspection-readiness initiatives across teams.
• Manage compliance oversight of third-party vendors and business partners.
• Support and monitor Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs).
• Ensure contractual obligations and compliance requirements are met.

Kenntnisse

Leadership

Quality management

Regulatory inspections

Stakeholder management

CAPA management

KPIs

Ausbildung

Bachelor's degree in Life Sciences or related field

Jobbeschreibung

Senior Pharmacovigilance Quality & Compliance Lead (AD Level)

Summary

This is a strategic leadership role focused on ensuring the effectiveness, compliance, and continuous improvement of the global Pharmacovigilance Quality Management System. You will oversee audit and inspection readiness, PV agreements, training programs, quality processes, and compliance monitoring while partnering with stakeholders across Safety, Quality, Regulatory, and external partners globally.

This is an excellent opportunity for someone who enjoys building robust systems, influencing global teams, and driving operational excellence in patient safety.

Responsibilities

Quality & Compliance Leadership

• Lead and enhance the global Pharmacovigilance Quality Management System
• Drive continuous improvement initiatives, issue management, CAPAs, and KPI development
• Ensure compliance with global PV regulations and quality standards

Audit & Inspection Readiness

• Coordinate and support global pharmacovigilance audits and regulatory inspections
• Lead inspection preparedness activities and support audit responsesManage findings, corrective actions, and compliance remediation plans
• Develop and manage global pharmacovigilance training programs
• Oversee SOP, procedural document, and document control activities
• Deliver training and support inspection-readiness initiatives across teams
• Manage compliance oversight of third-party vendors and business partners
• Support and monitor Pharmacovigilance Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs)
• Ensure contractual obligations and compliance requirements are met

Governance & Performance Management

• Monitor quality metrics and compliance indicators
• Drive risk assessments, root cause analysis, and process optimization
• Provide strategic quality guidance to cross-functional stakeholders

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Healthcare, or a related scientific field
• 10+ years of pharmaceutical or biotech experience
• 5+ years of experience in Pharmacovigilance / Drug Safety
• Proven experience managing or developing PV Quality Management Systems
• Strong experience supporting regulatory inspections and audits globally
• Knowledge of global PV regulations including Europe, US, and Japan
• Experience with CAPAs, deviations, procedural documents, and compliance monitoring
• Excellent leadership, communication, and stakeholder management skills

Preferred Experience

• Experience in global biotech environments
• Vendor and alliance oversight experience
• Training program development and execution
• Experience with quality management or document management systems
• Strong background in inspection readiness and continuous improvement programs

This job title is not an exact reflection of the exact job title at this client. This client uses specific titles, often not reflective of seniority, and the title used is purely to give an indication to applicants as to the approximate leveling on the market. Your Planet Pharma Recruiter will be able to provide the exact title and grading upon application.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com