Italy_Medical Information Specialist & PV Officer

Celltrion Group provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world.
Celltrion Group offers biologics to about 110 countries, along with more than 30 global partners around the world. With hands-on experience and knowledge accumulated through years of working in the advanced pharmaceutical markets around the world, Celltrion Group has been securing distribution channels and providing patients with biosimilars at affordable prices.

We are searching for a brilliant Medical Information Specialist & PV Officer 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), patients, and internal stakeholders, the collection, assessment, documentation, 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, patients, 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 customer service teams;
• Participation in Advisory Boards and round tables for the creation of reports;
• 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 SPECIALIST

• Collect, review, and assess individual case safety reports (ICSRs) from healthcare professionals, patients, clinical trials, and literature;
• Enter and manage safety data in the pharmacovigilance database in compliance with regulatory timelines;
• Conduct follow-up activities for incomplete or unclear case information;
• Prepare and submit spontaneous AE reports to regulatory authorities and business partners;
• Assist in the preparation of periodic safety reports (e.g., PSURs, PBRERs) and Risk Management Plans (RMPs);
• Monitor relevant scientific literature for safety data and adverse event reports;
• 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);
• Respond to Product complain requests.

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 or regulatory affairs) 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