Associate Medical Director M-SERM, South Africa at Thermo Fisher Scientific

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Summarized purpose:

• 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, Signal detection reports and CSR).

Essential functions:

• Maintains understanding of methods for recording time spent on project and administrative tasks, expense submissions and travel.
• 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 answer all project/study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
• Provides safety reporting training on assigned projects/studies, as requested.
• Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc) as contracted.
• Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported in Clinical Trials.
• 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 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.
• Manages signal detection activities, scientifically reviews periodic safety reports, contributes to label updates, supports dossier maintenance and risk management activities.
• Serves as a consultant and spokesperson for the functional area or as an external spokesperson for the organization on highly significant matters. Creates formal networks with key decision makers.

Education/experience:

• MD or equivalent required. History of an active medical license highly preferred.
• Candidates should have at least one of the following:
• Clinical experience in having direct responsibility for diagnostic and treatment decisions (comparable to 2 years); Or
• Direct experience in medical review and assessment of safety information/Pharmacovigilance (comparable to 3 years).