GRAPS Patient Safety Operations, Post Marketing Manager

Overview

In this role you safeguard patient safety worldwide by leading post-marketing pharmacovigilance operations across Chiesi's global portfolio. You ensure data quality, compliance and safety data integrity while collaborating with international stakeholders to drive continuous improvement and inspection readiness. You will oversee global PV processes, elevate vendor governance, and support audits and CAPAs. This position sits at the core of a mission-driven R&D organization focused on sustainable medicine and patient well-being.

Retribuzione / Benefits

• pension
• private medical insurance
• wellbeing programme
• flexible benefits programme
• relocation support
• remote work options

Responsabilità

• Support the Safety Operations PM Head to embed regulatory requirements into processes and procedures
• Oversee data collection aligned with safety strategy and ensure timely, high-quality post-marketing safety data delivery
• Supervise literature safety evaluation at global and local levels
• Oversee company-sponsored digital channels and social media related to safety
• Engage customers, affiliates and stakeholders across functions and regions
• Participate in interdepartmental meetings and act as subject-matter expert for PV activities
• Ensure data reconciliations with affiliates and contractual partners; train internal and vendor staff
• Support PV service providers (PVSPs) Case Management activities and interact with Safety Science inputs
• Supervise PV operations-relevant documentation for ODCS PV topics and contract clauses
• Oversee PV activities with CROs, including reconciliations and governance of PV agreements
• Ensure PSMF data integrity; manage deviations and CAPA plans
• Prepare for and support GVP audits/inspections; lead interviews and CAPA follow-ups
• Lead process improvement initiatives within the GRAPS department
• Maintain regulatory, policy and procedure compliance

Requisiti fondamentali

• Degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or related field
• Solid experience in Pharmacovigilance Operations in pharma/biotech/healthcare
• Strong knowledge of global pharmacovigilance regulations and GVP
• Experience managing safety data collection, quality, and timely reporting
• Proven ability to work with cross-functional and international stakeholders
• Excellent communication, influencing and stakeholder engagement skills
• Experience with external vendors and service providers and ensuring oversight
• Strong analytical, problem-solving and continuous improvement mindset
• Experience supporting audits, inspections or compliance activities in a regulated environment
• Professional English proficiency
• Influencing
• Stakeholder engagement
• Cross-functional collaboration
• Post-marketing safety data collection
• GVP knowledge
• Safety data management and reconciliation