Sr. Medical Director, Drug Safety

Medical Degree At least 12 years of drug safety and pharmacovigilance experience At least two years of oversight management experience 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 Demonstrated ability to successfully manage a drug safety team or drug safety CRO 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 Management of compliance deviations and formulation of CAPAs Familiar with clinical trial safety database use and CIOMS II and DSUR reporting generation (Argus, ArisG, or VeevaSafety) and Microsoft Office Suite required

Oversight and understanding of all aspects of the assigned product’s safety profile Chair of the Safety Management Committee for designated product(s) 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