Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description

Summarized Purpose:
Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports (e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labelling reconciliation documents, CTD modules, REMS, RMP and CSR).

General Support:
Ensures tasks delegated to pharmacovigilance are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to PPD’s corporate policies and SOPs/WPDs.



Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately. Provides therapeutic training and protocol training on assigned studies, as requested. Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns. Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete. Contributes to departmental process improvement initiatives.

Clinical Trial Support:
Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of

📌 Medical Director (Ciudad de México)
🏢 Thermo Fisher Scientific
📍 Ciudad de México