▪ Coordination of the infrastructures, services and personnel involved in the pharmacovigilance processes, in order to ensure that the System itself is constantly efficient, controlled and documented;▪ Ensure the presence of Standard Operative Procedures, with the relative records for the interventions carried out or the conclusions reached regarding: • Staff training • Deviations • Audit findings • Corrective Actions / Preventive Actions • Change Controls • Internal / External audits▪ Verification that the operations are carried out and documented according to the approved procedures;▪ Plan, carry out and verify the training for personnel involved in the Quality System for pharmacovigilance▪ Review and approve management documents relating to pharmacovigilance, collaborating in the management and participates in activities relating to the quality system of pharmacovigilance;▪ Periodically monitoring of the progress and effectiveness of the Quality Management System, in order to implement the measures necessary for its improvement;

▪ Medical sales representatives training, monitoring and activity reporting to the competent authorities▪ Advertising mediums preparation, review and approval▪ Medicines samples management▪ Scientific literature research

~ Regulatory activities related to the market entry and the maintenance of medicinal products (branded, generic, OTC) in the italian and EU market, through: • Evaluation of the projects and of the regulatory strategy • Support to the Marketing and Business Development Depts to assess the commercial potential of the projects • Analysis and mapping of the regulatory requirements of the projects • Coordination of internal and external professionals to meet the regulatory requirements • Submission of dossiers in CTD and eCTD format • Updating of dossiers in CTD and eCTD format • Submission of applications for variations (IA, IB, II) • Compliance activities (in collaboration with QA, QC departments) • Submission of applications for renewals • SPC and PL update

~ Regulatory activities related to the market entry and the maintenance of medicinal products (branded, generic, OTC) and food supplements in the italian and EU market, through: • Support to the Marketing and Business Development Depts to assess the commercial potential of the projects • Submission of dossiers in CTD and eCTD format • Updating of dossiers in CTD and eCTD format • Submission of applications for variations (IA, IB, II) • Compliance activities (in collaboration with QA, QC departments) • Submission of applications for renewals • SPC and PL update~ Pharmacovigilance activities, like: • Preparation of pharmacovigilance reports (PSUR, signal detection); • Case import

• Medications preparation and dispensation by interpreting prescriptions and physician orders• Counseling patients on drug therapies• Preparation of galenic products with laboratory management• Contact with suppliers, sales agents and sales representatives

• Medications preparation and dispensation by interpreting prescriptions and physician orders• Counseling patients on drug therapies• Preparation of galenic products with laboratory management• Contact with suppliers, sales agents and sales representatives