GRAPS Safety Operations, Clinical Trials Manager

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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 the expert for activities under

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7bvi5u