Italy_Medical Information Specialist & PV Officer
Core
Providing scientific and medical information to healthcare professionals and patients while managing adverse event reporting and safety data 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 background, experience in medical information or pharmacovigilance, ability to assess adverse events, knowledge of regulatory timelines, literature monitoring
Preferred skills
experience in advanced pharmaceutical markets, cross-functional project participation
Technologies
pharmacovigilance database
Responsibilities
Answer medical and scientific inquiries from healthcare professionals and patients; Develop and maintain Standard Response Letters; Collect, review, and assess individual case safety reports (ICSRs); Enter and manage safety data in compliance with regulatory timelines; Prepare and submit spontaneous AE reports to regulatory authorities; Support audits and inspections related to pharmacovigilance processes
Seniority
Mid-level, hands-on IC
