PSI CRO

Global CRO delivering on-time patient enrollment

Regulatory Officer - Safety Reporting

Biology & BiotechPosted on Nov 10

Full-timeSão Paulo, State of São Paulo, BrazilNo salary listed

About the Job

Requirements

A college or university degree, or an equivalent combination of education, training, and experience.
Prior experience in clinical research is required, with a focus on regulatory aspects of safety reporting.
Full working proficiency in English.
Proficiency in Microsoft Office applications.
Ability to plan and multitask while working in a dynamic team environment with tough deadlines.
Communication and collaboration skills.

Responsibilities

Serve as the point of contact for clinical project teams, support services, and client companies on safety reporting matters.
Coordinate accurate and timely reporting of safety issues to authorities.
Manage documents, including filing, processing, and quality control.
Update and maintain tracking systems, knowledge repositories, working files, and schedules.

Desired Qualifications

A degree in Life Sciences.

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.

About the Company

PSI CRO

Global CRO delivering on-time patient enrollment

PSI CRO is a global contract research organization that handles clinical trials for multiple therapeutic areas, with a focus on enrolling patients on schedule and delivering studies on time. Its services span feasibility assessments, trial planning, site selection, patient recruitment, and multi-continent trial execution across 50+ countries, backed by medical doctor resources dedicated to accurate timeline predictions. Unlike many CROs, PSI emphasizes predictable enrollment and on-time project delivery, aiming for high client satisfaction and repeat business through a pragmatic, no-nonsense approach. The company’s goal is to be regarded as the best CRO in the world by both clients and employees, achieved through reliable timelines, strong execution, and low staff turnover.

Company size: 1,001-5,000
Company stage: Not listed
Total funding: Not listed
Headquarters: Switzerland
Founded: 1995

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