Contributes in identifying and analysing safety signals based on a comprehensive evaluation of pre- and post- marketing data, including respective literature searchContributes in preparation of safety Committee meetings and drafting meeting minutesContributes in single case assessments (ICSRs, and SAEs from clinical trials), with provision of medical and PV expertiseContributes to ensure that the documentation and follow- up processes on AE case reports maintains… Show more Contributes in identifying and analysing safety signals based on a comprehensive evaluation of pre- and post- marketing data, including respective literature searchContributes in preparation of safety Committee meetings and drafting meeting minutesContributes in single case assessments (ICSRs, and SAEs from clinical trials), with provision of medical and PV expertiseContributes to ensure that the documentation and follow- up processes on AE case reports maintains compliance with regulatory requirementsProvides support in the preparation and update of Standard Operating Procedures related to the risk management activities Show less

Management of post-marketing, literature and clinical trial ICSRs: Medical Review and Assessment (MRA) with clinical analysis, Quality Control (QC), Data Entry.Medical analysis of adverse event reports for all Menarini products in post-marketing and clinical studies (triage, medical assessment and company comments at single case-level).Management of adverse reactions with discussions with Local Drug Safety Managers and International Drug Safety Coordinating Units, with Local… Show more Management of post-marketing, literature and clinical trial ICSRs: Medical Review and Assessment (MRA) with clinical analysis, Quality Control (QC), Data Entry.Medical analysis of adverse event reports for all Menarini products in post-marketing and clinical studies (triage, medical assessment and company comments at single case-level).Management of adverse reactions with discussions with Local Drug Safety Managers and International Drug Safety Coordinating Units, with Local Drug Safety Managers for clinical studies, with Licensors and Partners. Activities with Drug Safety CIOMS: submission to Health Authorities, Licensors, Partners, LQPPV/LDSUM.Management of deviations. Medical support in preparation of periodic drug safety papers for the assigned drugs (PSUR, DSUR, RMP, ecc), and medical support in phone-conference with Licensors.Monitoring the medicinal product safety profiles through their life-cycle.Accountable referent at corporate level for any communication or query in regards to the Risk Management Plans, PSURs/DSURs for the assigned drugs. Show less