4 jobs found in north wales

Job DescriptionUnder the general direction of the Clinical Safety and Risk Management Group Lead, the CSRM Physician is an is responsible for the overall clinical risk management and safety surveillance of assigned investigational and marketed products. This includes all aspects of safety monitoring including assessing safety information and ensuring completeness of safety information in worldwide package circulars. The incumbent is also responsible for the development of post-market risk management plans and pharmacovigilance strategies/specifications.Primary ResponsibilitiesThe incumbent is a member of the Product Development Teams and chairs the Risk Management and Safety sub team for assigned products. Partners with appropriate company departments and therapeutic area heads to ensure efforts are aligned to meet our global risk management strategies for assigned products. Works with CSRM Group Lead to plan direction for risk management functions of the department, helps develop...

Job Description We are seeking candidates with an entrepreneurial and learning spirit who are interested in a career of purpose, personal growth and leadership. Supports the CSRM team in the safety surveillance of assigned products. Proficient in data retrieval and preliminary analysis of safety data for responses to inquiries from health professionals, regulatory agencies and other customers regarding adverse experiences reported. Medical review of serious adverse experience reports and other AE reports of interest to monitor and describe the safety profile of assigned products. Takes a leadership role in the oversight and development of pharmacovigilance and risk management plans. This includes the authoring of periodic safety update reports (PSURs) and other regulatory documents Functional area expert with primary ownership of designated CSRM programs. Position can be based Remotely. Primary Responsibilities: Advanced knowledge and understanding of safety...

Job Description Essential function(s) includes, but is not limited to: Performs primary medical review of serious adverse experience reports and other AE reports of interest to monitor and describes the safety profile of assigned products; taking an active role in the oversight and development of pharmacovigilance and risk management plans under the overall direction of the Clinical Safety and Risk Management physician/senior management.. Leads preparation regulatory documents and responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for our company's marketed products; strategizes with safety team recommending appropriate data to respond to queries and analyze data. Position can be Remotely BasedPrimary Activities Primary activities include, but are not limited to: Independently working to expand and apply clinical, pharmacological, and epidemiologic knowledge and information technology skills to managing the safety...

Job DescriptionEssential function(s) includes, but is not limited to:Performs primary medical review of serious adverse experience reports and other AE reports of interest to monitor and describes the safety profile of assigned products; taking an active role in the oversight and development of pharmacovigilance and risk management plans under the overall direction of the Clinical Safety and Risk Management physician/senior management.. Leads preparation regulatory documents and responses to inquiries from health professionals and regulatory agencies regarding adverse experiences reported for our company's marketed products; strategizes with safety team recommending appropriate data to respond to queries and analyze data.Position can be Remotely BasedPrimary ActivitiesPrimary activities include, but are not limited to:Independently working to expand and apply clinical, pharmacological, and epidemiologic knowledge and information technology skills to managing the safety surveillance...