Italy_Medical Information Specialist & PV Officer
Core
Providing scientific and medical information to healthcare professionals and managing adverse event reporting for biosimilar and biopharmaceutical products.
Role type
Medical Information Specialist & Pharmacovigilance Officer
Builds
Standard Response Letters, safety reports, and regulatory documentation for Celltrion's medicinal products
Domain
Biopharmaceuticals / Biosimilars
Deliverable
client delivery | dashboards & analysis
Required skills
Scientific degree in medicine, pharmacy, or biology; Fluency in English; Knowledge of Rheumatology, Gastroenterology, Oncology, Hematology, Allergology, or Pneumology; Experience in Medical Information and/or Pharmacovigilance
Preferred skills
PhD or Master's degree; Experience in Italy; Knowledge of biological/biosimilar drugs
Technologies
Pharmacovigilance databases
Responsibilities
Answer medical inquiries from HCPs and patients; Develop and maintain Standard Response Letters; Collect, assess, and report adverse events (ICSRs); Prepare periodic safety reports (PSURs, PBRERs) and Risk Management Plans; Monitor scientific literature for safety data; Support audits and inspections
Seniority
Mid-level, hands-on IC
