Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas
Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER)
Responsible for signal detection and management activities including, but not limited to STAR maintenance, ISMP maintenance
Contribute to the strategy and review of safety assessments and drug safety reports for signals or issues (inc, product quality) or in response to Regulatory Authority requests
Contribute to the development of the product safety strategy and provide drug safety input into the Clinical Development strategy
Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance (including the IB), risk communications, RMP, REMS
Participate in and provide input for Drug Monitoring Committees (iDMC) or internal monitoring committee (IMC) meetings, as applicable
Author or contribute to scientific publications (abstracts, posters, papers) for scientific meetings/journals
Acts independently to manage safety responsibilities on study teams and in activities supporting safety science
They will provide clinical medical expertise and decision-making, in areas where this is specifically required to support colleagues in PCS
Requirements
Formal medical qualifications (e.g. MD; MB BS; MB ChB) and have post-graduate experience in one or more areas of clinical medical practice including in medical specialities/disciplines that are relevant to clinical safety and/or to the therapy/disease areas in which the company develops and markets medicines
Qualified healthcare professional or Life Sciences graduate
Understanding of GxP and regulated processes and end to end clinical trial lifecycle
Strong orientation towards process improvement and cross-functional teamwork
Excellent communication skills, both written and verbal
Apply complex data analysis / statistical methods to evaluate, interpret and present scientific data with clarity
Strong presentation skills, effective at summarizing and presenting the key considerations and decision points
Ability to effectively train others on departmental practices and processes
Application of project management methodology
Fluent in Mandarin and English
Benefits
Our culture encourages personal expression, open dialogue, and genuine connections