Responsibilities: Develop and execute global clinical development strategy, and communication of the global scientific/medical evidence plan for multiple indications Provide clinical/scientific input during the development and execution of clinical trials, including key observational studies Provide clinical content input to: Regulatory …..
Support various pharmacovigilance and risk management/minimization activities for investigational and marketed products Responsibilities: Author and coordinate/project manage development of periodic safety reports (e.g., PSUR/PBRER, PADER, DSUR, etc) Support preparation and maintenance of Risk Management plans Contribute to development of signal …..
The Director leads the project teams to design and implement clinical studies at high quality and in a time- and cost-effective manner in line with the department and corporate goals and within regulatory and resource guidelines. Responsibilities: Provide medical monitoring …..
The Global Publications Lead will work cross-functionally with clinical development, biostatistics, and key business partners to execute on tactics consistent with overall in-line and pipeline strategy. Responsibilities: Achieve subject matter expertise in Cell Therapy to lead cross-functional, Global Publication Planning …..
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The Associate Director, Pharmacovigilance & Epidemiology, under the guidance of the Director of Medical Safety Science, Risk Management, is responsible for liaising with PVE Operations, managing clinical trial support activities, and accessing data for Aggregate Reports. The candidate should be …..