This is what you will do
- Carry out pharmacovigilance (PV) operations (OPS) activities in interventional clinical trials sponsored either by GCD or GRD functions by maintaining up-to-date processes for safety-related aspects of interventional clinical trials, to meet current and evolving PV legislation. You will be responsible for
- Support the GRAPS Safety Operations CT Head in ensuring all current PV requirements for interventional clinical trials are effectively incorporated into Chiesi processes and documented in procedures.
- Ensure strategic collection, assessment and delivery of high‑quality clinical trial safety data in a timely manner, ensuring that it is correct, consistent, compliant and delivered to agencies.
- Actively engage CT customers, affiliates and other stakeholders.
- Participate in interdepartmental meetings inside and outside R&D.;
- Act as owner (subject matter expert) for specific processes under the area of competency of CT PV OPS Unit, responsible for implementing requirements, training, procedure maintenance, vendor oversight.




- Provide appropriate training to relevant internal and vendor staff for these processes, as applicable.
- Support the Case Management team for activities performed by Pharmacovigilance Service Providers (PVSPs).
- Interact with the Safety Science team for product‑specific safety strategy data collection inputs.
- Supervise and/or review PV operations‑relevant sections of documents pertinent to clinical trials with regards to PV topics/involvement.
- Oversee PV operations activities with concerned Contract Research Organizations (CROs).
- Ensure data related to each process under the area of competency of CT PV OPS team are properly filled out in the PSMF.
- Open deviations related to the activities under the role and contribute to the investigation(s) and CAPA Plan implementation.
- Manage PV OPS activities throughout Post‑Integration phases, for R&D; assets.
- For all GVP and GCP audits and inspections, serve as th

📌 Patient Safety Operations Manager (Italia)
🏢 Chiesi Group
📍 Italia