Medical Director/Associate Medical Director; Neurology …, Buenos Aires

Work ScheduleStandard Office Hours (40 per week) Environmental ConditionsOffice Job DescriptionAs part of the Thermo Fisher Scientific team you will discover meaningful work that makes a positive impact on a integral scale. Our 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. Responsibilities
- Provide medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed.
- Attend and present at investigator and sponsor meetings, provide medical consultation to clients, investigators and project team members, and support business development activities.
- Provide 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).
- Ensure tasks delegated to PVG are properly executed.
- Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues.
- Adhere to client SOPs/directives and project specific WPDs for assigned projects.
- Adhere to PPD's corporate policies and SOPs/WPDs.
- Provide medical consultation to team members and answer all study‑related medical questions.
- Communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
- Provide therapeutic training and protocol training on assigned studies, as requested.
- Assist 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 medical content is accurate and complete.
- Monitor all safety variables (AE, laboratory abnormalities, change Postúlate en Kit Empleo: kitempleo.com.ar/empleo/qh0d5