Medical Science Liaison
Há 7 dias
Company: PSI CRO
Job Title: Medical Monitor
Location: Home-Based in Brazil
Job Type: Full-time
Industry: Pharmaceutical
Job Description:
Key Responsibilities:
- Provide medical input to global clinical studies and advise teams and business partners 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 analyze 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.
- Assist in Pharmacovigilance activities.
- Identify program risks and create and implement mitigation strategies with Clinical Operations.
- 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:
- 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.
- Strong communication, presentation, and analytical skills.
- Problem-solving, team-oriented, and detail-oriented.
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