Safety Officer, Medical Information Specialist

Summary

Join our global team as a Freelance Local Safety Officer and Medical Information Specialist in Italy! This remote, 0.4 FTE position requires managing daily operations, ensuring compliance, exchanging safety information, and serving as a contact for timely safety processing. You will work closely with Italian pharmacovigilance support personnel. The ideal candidate will have a strong background in pharmacovigilance and a demonstrated ability to interpret and apply relevant regulations. Submit your CV in English for consideration.

Requirements

• Degree in Medicine, Biomedicine, Pharmacist or Nurse
• Fluent written and spoken English and native Italian
• In-depth, demonstrated experience in most areas pertaining to pharmacovigilance and pharmacovigilance legislation
• Excellent knowledge of local and international regulations (ICH, EU GVP Modules)
• Analytical skills to understand, analyze, interpret, and present scientific data
• Ability to interpret and apply global and local drug safety regulations
• High motivation to develop and learn within the team

Responsibilities

• Become nominated Local Safety Officer to Italian NCA
• Perform local PV operations and ensure compliance with safety regulations and procedures
• Manage ICSRs and FUs
• Serve as the main contact for safety matters with authorities and clients
• Review local literature
• Perform PV trainings to MAH employees
• Handle Medical Information Requests
• Support Biomapas Clients with other PV related tasks

Preferred Qualifications

Preferably at least 2 years experience in pharmacovigilance