Medical Science Liaison

Há 6 dias

São Paulo, São Paulo, Brasil PSI CRO Tempo inteiro
Job Description

**About PSI CRO**

PSI CRO is a leading Contract Research Organization with over 25 years of experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Summary

As a Medical Monitor at PSI CRO, you will provide medical input to global clinical studies and advise teams and business partners on medical matters, while always focusing on patients' safety and well-being.

Responsibilities

  1. Medical Input and Advice

Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies, and third-party vendors on medical matters.

Clinical Development Planning

Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations.

Data Review and Analysis

Review and analyze clinical data to ensure the safety of study participants in clinical studies.

Quality Assurance

Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments.

Safety Issue Resolution

Address safety issues across the study from sites and the study team.

Medical Dictionary Verification

Review listings for coded events to verify Medical Dictionary for Regulatory Activities.

Pharmacovigilance Activities

Assist in Pharmacovigilance activities.

Risk Management

Identify program risks and create and implement mitigation strategies with Clinical Operations.

Advisory Boards and Safety Monitoring Boards

Organize and lead clinical development advisory boards and safety monitoring boards.

Compliance and Regulatory Affairs

Ensure study team compliance with FDA, EMEA, ICH, and GCP guidelines.

Clinical Document Review

Review and sign off clinical documents with respect to medical relevance.

Qualifications

  1. Internal Medicine Certification

Internal Medicine certification is a must.

Medical Experience

Prior and wide experience in medical practice/patient care (minimum of 10 years).

Clinical Trials Experience

Prior experience working with clinical trials is a plus.

ICU Experience

Prior experience with ICU is a plus.

Language Proficiency

Full working proficiency in English and Portuguese.

Technical Skills

Proficiency with MS Office applications.

Soft Skills

Strong communication, presentation, and analytical skills.

Problem-Solving and Teamwork

Problem-solving, team-oriented, and detail-oriented.

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