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Local Safety Officer / Medical Information Specialist (Freelance role)

extra parental leave - fully flexible
Remote: 
Full Remote
Contract: 
Experience: 
Mid-level (2-5 years)
Work from: 

Offer summary

Qualifications:

Degree in Medicine, Biomedicine, Pharmacist or Nurse, Fluent in English and native Italian, At least 2 years of experience in pharmacovigilance, Excellent knowledge of local and international regulations..

Key responsabilities:

  • Become nominated Local Safety Officer to Italian NCA
  • Perform local PV operations and ensure compliance with safety regulations
  • Serve as the main contact for safety matters with authorities and clients
  • Handle Medical Information Requests and support Biomapas Clients.

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Biomapas SME http://www.biomapas.com
201 - 500 Employees
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Job description

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

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 0.4 FTE position in Italy, working in close collaboration with Italian local pharmacovigilance support personnel. 

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 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

Requirements

·       Degree in Medicine, Biomedicine, Pharmacist or Nurse

·       Fluent written and spoken English and native Italian

·       Preferably at least 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

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
EnglishItalian
Check out the description to know which languages are mandatory.

Other Skills

  • Teamwork
  • Self-Motivation
  • Communication

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