GRAPS Safety Operations, Clinical Trials Manager

Overview

In this role you will carry out pharmacovigilance (PV) operations for interventional clinical trials, ensuring compliant, high-quality safety data and up-to-date processes. You'll work with global teams and CROs to support PV requirements across R&D assets. You will train staff, oversee audits, and drive process improvements within a collaborative, international environment. This position offers a clear impact on patient safety and regulatory excellence at Chiesi.

Retribuzione / Benefits

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

Responsabilità

• Support CT PV OPS processes and ensure PV requirements are embedded in Chiesi procedures
• Coordinate collection, assessment and timely delivery of safety data to agencies
• Engage CT customers, affiliates and stakeholders across the organization
• Act as subject matter expert for PV OPS processes and provide training
• Support Case Management activities with PVSPs
• Interact with Safety Science for product-specific safety data inputs
• Supervise PV operations-related sections of trial documents and oversee CRO activities
• Ensure PV data capture in PSMF and manage deviations/CAPA implications
• Lead post-integration PV OPS activities for R&D assets
• Serve as PV OPS expert during GVP and GCP audits and inspections
• Participate in GRAPS process improvement initiatives
• Maintain compliance with regulations, policies and procedures

Requisiti fondamentali

• Master degree in science, medicine, biology, pharmacy or related fields
• Minimum 4 years in R&D in Pharmaceutical/Biotechnology, with at least 3 years in Pharmacovigilance or Clinical Research
• Willingness to operate in a diverse, international environment
• Excellent communication and interpersonal skills
• Ability to work with initiative and autonomy
• Problem solving and decision making skills
• Planning and analytical skills
• Fluent English
• Excellent communication
• Autonomy and initiative
• Problem solving
• Global pharmacovigilance knowledge
• GCP awareness
• MedDRA coding knowledge