Medical Director/Associate Medical Director; Neurology …, Lomas de Zamora

Work ScheduleStandard Office Hours (40 per week) Job DescriptionAs part of the Thermo Fisher Scientific team you will discover meaningful work that makes a positive impact on a general scale. Location / Division Specific InformationOur detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs in clinical trials, oversee case‑processing activities through all phases of development and perform regulatory reporting and medical monitoring. Discover Impactful WorkThe Associate/Medical Director 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. labeling reconciliation documents, CTD modules, REMS, RMP and CSR). ResponsibilitiesA Day in the Life General Support
- Ensures tasks delegated to PVG 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 answers 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.
- Assists in writing and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medica Postúlate en Kit Empleo: kitempleo.com.ar/empleo/qh5er