Medical Information Specialist
2 settimane fa
We 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.
The new colleague will be responsible for providing accurate, balanced, and evidence-based scientific and medical information regarding the Celltrion's products to healthcare professionals (HCPs) and internal stakeholders, the collection, and reporting of adverse events (AEs) serious and non-serious and other safety information related to the company's medicinal products.
Joining the Medical team and reporting to the Medical Manager, the new resource will be responsible for
MEDICAL INFORMATION SPECIALIST
- Answer to 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
- Collect, review, and assess individual case safety reports (ICSRs) from healthcare professionals, clinical trials, and literature;
- Collaborate with external office for all activities related to PV and local responsible of reconciliation 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
Essential requirements
- Scientific Degree (medicine, pharmacy, biology or equivalent);
- Achievement of PhD and/or master program (best 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 roles (Medical Info & Pharmacovigilance) in pharmaceutical company in Italy (best but not mandatory);
- Knowledge and experience in Rheumatology, Gastroenterology, Oncology, Hematology, Allergology, Pneumology, biological/biosimilar drugs (best 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.
Workplace: Milan, office based
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