Medical Information Specialist

1 settimana fa


Milano, Italia Celltrion Healthcare Italia A tempo pieno

Medical Information Specialist & PV MonitorWe are searching for a brilliant Medical Information Specialist & PV Monitor with a strong scientific background and a previous experience (at least two years) in a similar role to join our Medical Affairs Department.ResponsibilitiesThe new colleague will be responsible for providing accurate, balanced, and evidence-based scientific and medical information regarding Celltrion's products to healthcare professionals (HCPs) and internal stakeholders, and for the collection and reporting of adverse events (AEs) serious and non-serious and other safety information related to the company's medicinal products.Medical Information Specialist ResponsibilitiesAnswer medical and scientific inquiries from healthcare professionals and internal teams in a timely and compliant manner;Develop and maintain standard response letters and other medical information materials;Monitor scientific literature and ensure that responses and materials reflect the latest evidence and clinical data;Participate in cross-functional projects within Medical Affairs;Contribute to internal scientific training for field-based and office colleagues;Participation in advisory boards and round tables for the creation of reports (if necessary);Ensure proper reporting and follow-up of adverse events and product complaints in collaboration with the Pharmacovigilance department;Support the medical review of promotional and non-promotional materials for scientific accuracy and regulatory compliance;Pharmacovigilance Monitor ResponsibilitiesCollect, review, and assess individual case safety reports (ICSRs) from healthcare professionals, clinical trials, and literature;Collaborate with external offices for all activities related to PV and local reconciling activities;Assist in the preparation of Risk Management Plans (RMPs);Collaborate with Medical Affairs, Regulatory, and Quality departments for cross-functional safety activities;Support audits and inspections related to pharmacovigilance processes and documentation;Maintain up-to-date knowledge of global pharmacovigilance regulations (e.g., EMA, FDA, MHRA);Ensure internal scientific training on PV for all new employees;QualificationsScientific degree (medicine, pharmacy, biology or equivalent);Achievement of PhD and/or master program (preferred but not mandatory);Fluency in English;Deep understanding of all biology and medicine related aspects of the therapeutic areas assigned;Experience in the pharmaceutical industry, preferably in a medical role (Medical Info & Pharmacovigilance) in a pharmaceutical company in Italy (preferred but not mandatory);Knowledge and experience in Rheumatology, Gastroenterology, Oncology, Hematology, Allergology, Pneumology, biological/biosimilar drugs (preferred but not mandatory);Ability to work independently and in cross-functional teams in a fast-paced environment;Excellent organizational and analytical skills with attention to detail.WorkplaceMilan, office based#J-*****-Ljbffr



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