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Regulatory Officer

Role overview

Summary

This role supports regulatory safety reporting for clinical research projects at the company, which focuses on bringing new medicines to those in need. You will coordinate communication and document management, ensuring compliance with safety reporting requirements.

Qualifications

  • College/University degree or an equivalent combination of education, training & experience.
  • Prior experience in Clinical Research with focus on regulatory aspects of safety reporting
  • Full working proficiency in English
  • Proficiency in MS Office applications
  • Preferred: Ability to plan, multitask and work in a dynamic team environment with tough deadlines

Responsibilities

  • Support regulatory safety reporting aspects of clinical research projects
  • Coordinate accurate and time-bound reporting of safety issues to authorities
  • Manage document management tasks, including filing and quality control
  • Update and maintain tracking systems and schedules

Key facts

Hard skills

Other skills

  • Microsoft Office
  • Time Management
  • Communication
  • Collaboration
  • Multitasking

About the company

PSI CRO AG  logo

PSI CRO AG

  • Clinical Research (CRO)
  • Large
  • 1,001–5,000
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com

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Job description

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do.  A dynamic, global company founded in 1995, we bring together more than 3,200 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. 

Job Description

Join our international team and support regulatory safety reporting aspects of clinical research projects, streamlining communication, maintaining electronic systems and managing documents.

Office-Based in São Paulo

You will:

  • Be the point of contact for clinical project teams, support services and client companies on safety reporting matters
  • Coordinate accurate and time-bound reporting of safety issues to authorities
  • Be responsible for document management, such as filing, processing, and quality control 
  • Update and maintain tracking systems, knowledge repositories, working files, and schedules

Qualifications

  • College/University degree or an equivalent combination of education, training & experience
  • Life Sciences degree is a plus
  • Prior experience in Clinical Research required, with focus on regulatory aspects of safety reporting
  • Full working proficiency in English
  • Proficiency in MS Office applications
  • Ability to plan, multitask and work in a dynamic team environment with tough deadlines
  • Communication and collaboration skills

Additional Information

Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.

Please let us know if any additional information is needed at this point. And as agreed, would be great fi you set up a Teams chat for Natalia and me, so that we could promptly see your messages and react to them.

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