Michelle Langley Email and Phone Number

The Global Safety Scientist Lead (GSSL) is an independent individual contributor providing deep technical and scientific expertise to products in all stages of development from Phase 1 through post-marketing. The GSSL is a core member of the Global Safety Team (GST) for assigned product(s), providing pharmacovigilance expertise through contributions, deliverables and activities on highly complex projects requiring a more advanced level of pharmacovigilance expertise. The GSSL can serve as a delegate for the Global Safety Officer.Key Activities in clinical trial safety include review and strategic input on study protocols, statistical analysis plans and other clinical study-related documents and reference safety information. Regarding signal detection and safety evaluation and management activities, the GSSL is a key contributor to the signal detection strategy, the review of all safety information and the planning and authoring of safety assessment reports and other safety and regulatory responses.The GSSL is a key contributor to risk management and minimization activities, including assisting with development of the risk management strategy, development and updating of risk management plans and oversight of risk minimization activities. Periodic safety reporting to global health authorities, including planning and authoring, is another important responsibility of this position.Compliance, including planning and implementing Corrective Action and Preventive Actions (CAPA) is a key component of this position. Finally, the GSSL assumes the leadership role for a team of 4-7 scientists. The position is responsible for hiring, onboarding and mentoring newer scientists in all aspects of pharmacovigilance.