In this role you will lead the strategic direction for Clinical Drug Safety, overseeing the evaluation of the safety profile of our products throughout their lifecycle. You will also shape and implement safety standards and drive the overall safety strategy supporting our clinical development programs.
Responsibilities:
- Provide medical expertise and judgement in safety surveillance activities including periodic safety reports, safety signal detection, and in creation and updates of development risk management plans.
- Evaluate and manage risks associated with assigned projects and make recommendations for the management communication of risks, in accordance with global legal and regulatory frameworks.
- Lead the Signal Detection process for the CatalYm projects
- Provide Safety medical expertise and judgement in the production of high quality and timely Safety documents such as DSURs, Safety Summaries and Overviews for regulatory submissions.
- Perform the medical review of serious adverse event reports, including sponsor causality and expectedness assessment
- Implement and oversee the execution of Safety Data Exchange Agreements in projects where CatalYm is partnering in clinical development
- Provide medical Safety expertise to ensure high quality and timely responses to safety queries from all sources, including Regulatory Authorities.
- Provide medical expertise and judgement to Project Teams with respect to safety aspects of the design and preparation of trial protocols, investigators brochures, investigator letters and reports, for the follow up and processing of clinical trial data and lead the safety analyses of the assigned projects.
- Provide medical Safety input during development of relevant SOPs, working instructions, and guidelines. Owner of the CatalYm Safety System within the overall Quality Management System