Local Safety Officer

2 days ago

Estonia Biomapas Full time €30,000 - €60,000 per year

Freelance opportunity in Estonia Join our global team as a deputy Local Safety Officer and Medical Information Specialist in Estonia.

Deputy Local Safety Officer and Medical Information Specialist is responsible for managing daily operations, ensuring compliance, exchanging safety information and serving as a contact for timely safety processing.

Position is remote for 0.3 FTE deputy role in Estonia, working in close collaboration with current Estonian local pharmacovigilance team.

You have energy and motivation to work in a team and to gain more experience?

Submit your CV in the English language for consideration.

Responsibilities:

  •      Become nominated Local Safety Officer to Estonian NCA (nomination as per local requirements)
  •      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
Requirements
  •      Biologist, Pharmacist, Medical Doctor, or other life science degree
  •      Fluent written and spoken English and native Estonian
  •      2 years experience in pharmacovigilance
  •      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

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