Company Description
PSI is a leading Contract Research Organization with more than 25 years 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 Description
PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.
Home-Based in Brazil
Responsibilities:
- Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
- Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
- Review and analysis of clinical data to ensure the safety of study participants in clinical studies
- 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
- Address safety issues across the study from sites and the study team
- Review listings for coded events to verify Medical Dictionary for Regulatory activities
- Participate in bid defense meetings
- Assist in Pharmacovigilance activities
- Identify Program risks, and create and implement mitigation strategies with Clinical Operations
- Ability to organize and lead clinical development advisory boards and safety monitoring boards
- Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
- Review and sign off clinical documents with respect to medical relevance.
Qualifications
- Medical Doctor degree
- Internal Medicine certification is a must
- Prior and wide experience in medical practice/patient care (minimum of 10 years)
- Prior experience working with clinical trials is a plus
- Prior experience with ICU is a plus
- Full working proficiency in English and Portuguese
- Proficiency with MS Office applications
- Communication, presentation and analytical skills
- Problem-solving, team and detail-oriented
Additional Information
As part of PSI's Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.
