5 days ago be among the first 25 applicantscompany descriptionpsi 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 descriptionpsi medical monitors provide medical input to global clinical studies and advise the teams and business partners, always prioritizing patients' safety and well-being.location: home-based in mexicoresponsibilities:advise clients, project teams, sites, data safety monitoring boards, regulatory agencies, and third-party vendors on medical matters.collaborate with internal departments in preparing clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and scientific presentations.review and analyze clinical data to ensure the safety of study participants.ensure accuracy, completeness, and verifiability of reported data, and compliance with approved protocols and 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 (meddra) coding.participate in bid defense meetings.assist in pharmacovigilance activities.identify program risks and develop mitigation strategies with clinical operations.organize and lead clinical development advisory boards and safety monitoring boards.ensure compliance with fda, emea, ich, and gcp guidelines.review and approve clinical documents for medical relevance.qualifications:medical doctor degree.oncology fellowship certification is mandatory.at least 10 years of experience as a practicing oncologist.proficiency in english and spanish.proficiency with ms office applications.strong communication, presentation, and analytical skills.problem-solving ability, team-oriented, detail-oriented.additional information:join psi's medical monitoring team to work with an international group of medical professionals, advancing medical science and helping bring new medications to patients in need.seniority levelmid-senior levelemployment typefull-timejob functionotherindustriespharmaceutical manufacturing
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