Senior Director, Drug Safety and Pharmacovigilance

Bachelor’s degree in a health care discipline or equivalent At least ten years of drug safety and pharmacovigilance experience At least 5 years experience in Clinical Development Safety Extensive experience with all aspects of safety signal evaluation Experience in both clinical development and post-marketing safety Experience with Regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviews Experience in drug safety audits and agency inspections Intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelines Proven ability to collaborate successfully with clinical trial teams Experience in managing all clinical safety aspects of product quality defect investigations and assessments Familiar with clinical trial safety database use and CIOMS II and DSUR reporting generation (Argus, ArisG, or VeevaSafety) Microsoft Office Suite required (Word, Excel, PowerPoint, Project, Outlook)

Oversight and understanding of all aspects of the assigned product’s safety profile Management of CROs and other partners Facilitate Safety Management Committee Establish the safety strategy for marketing authorization applications Support the clinical development team in the review of key documents Manage the drug safety contract service organizations (CROs) Assist in the medical review of adverse event reports Develop and prepare assessments of safety data, safety signals, and benefit/risk Assist in the authoring of aggregate reports