GRAPS Safety Operations, Clinical Trials Manager
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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
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