San Diego, CA30+ days ago
The Senior Director, Drug Safety Operations will be provide leadership and direction to the Drug Safety operations for adverse event case management, support of study teams and projects, oversight of maintenance of drug safety database, and collaboration to support risk management and pharmacovigilance, vendor oversight activities and ensures compliance and operational excellence for PV related activities. Support the Head of Clinical Safety & Pharmacovigilance in the review and development of written materials including clinical trial protocols, Informed Consent Forms, Case Report Forms, adverse event (AE)/ serious adverse event {SAE) reporting forms, Clinical Study Reports, and Investigator's Brochures (including Reference Safety Information determinations).