Raffaella Mancini Email and Phone Number

Fulfil the responsibility for the coordination and execution of all aspects of pharmacovigilance(PV) to ensure that all of AbbVie’s statutory and ethical responsibilities are met. Act as theAffiliate’s main contact point for pharmacovigilance matters with the nationalRegulatory Authority and AbbVie Headquarter Pharmacovigilance.Provide strategic leadership to manage and support the Pharmacovigilance (PV) teamto meet all global and local PV responsibilities

Fulfil the responsibility for the coordination and execution of all aspects of pharmacovigilance.To be the main Medical Department interface of the Commercial Excellence/BusinessTechnology Solutions team as for activities of medical in field personnel in order to guaranteecompliance and harmonization.To coordinate set up and continuous improvement and maintenance of high quality standard of key medical processes.

Provide support to the relevant Affiliate Medical Department functional areas, through Quality Control activities, in order to ensure that activities are executed in compliance with local and international regulations and company SOPs and with highest internal and external standards.Provide support to the relevant Affiliate Medical Department functional areas in the preparation activities of any audit/inspection in order to gain positive outcome.Implement and update Affiliate Medical Department systems and processes, ensuring compliance to local and international regulations and company international procedures.Warrant Quality control check on Medical Department Procedures and Guidelines before the approval and relevant timely distribution. Represent the primary point interface , as to the Medical Dept., for Ethics and Compliance aspects within the affiliate.Provide support to the relevant Affiliate Medical Department functional areas in personnel training planning and preparation activities.To be the main Medical Department interface of the Commercial Excellence/BusinessTechnology Solutions team as for activities of medical in field personnel in order to guaranteecompliance and harmonization.To coordinate set up and continuous improvement and maintenance of high quality standard of key medical processes.Since March 2019, added pharmacovigilance responsibilities as affiliate safety representative.

Responsible for the implementation and execution in Italy of assigned clinical studies, in compliance with all applicable regulations, processes and procedures and with agreed parameters.Responsible for line management of Affiliate Clinical Research Associates and Clinical Project Assistant. Responsible for definition and monitoring of internal and external resources needed for assigned clinical studies.Responsible for supervision of CRO personnel activities.Support in protocol design and development for affiliate sponsored clinical studies. Contribute to the design and improvement of Medical Department systems and processes.