Sandra Johnson

Background

About Sandra Johnson

Experienced as result driven leader of global pharmacovigilance programs providing strategic leadership and oversight for pharmacovigilance operations and risk management functions for products marketed worldwide including combination products and devices. Responsible for clinical and post-market adverse event case management activities (ICSR intake, SAE/AE assessment, MedDRA coding, narrative writing, and regulatory reporting submissions), client implementations, and development of standard operating procedures and work instructions. Provide oversight of literature surveillance, aggregate reports (PBRER, PADER, PSUR), and signal management. Project managed cross functional teams and successfully completed projects resulting in regulatory compliant procedures. Knowledgeable resource of global regulatory requirements including FDA US Code of Federal Regulations, EMA GCP and GVP legislation, and ICH guidelines. Proficient Argus safety database use. Efficient multi-tasker with a strong attention to detail and analytical skills to prioritize tasks and adhere to deadlines while working in a dynamic environment.