Patient Safety Operations Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7hvpwa

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.
Responsibilities 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
Qualifications 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
Benefits pension
private medical insurance
wellbeing programme
flexible benefits programme
relocation support
remote work options
J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7hvpwa