Drug Safety Associate II
Nature and Scope The Drug Safety Associate II will be responsible for the review, evaluation, and management of adverse event (AE) reports for all American Regent Inc., investigational and marketed products under the direction of the Sr. Manager of Pharmacovigilance. Essential Duties and Responsibilities Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Perform individual case safety report (ICSR) processing activities within the safety database ensuring quality and timely submission. Perform quality checks on assigned ICSRs. Performs reconciliation of safety data. Participate in Study Team meetings as the Safety and Pharmacovigilance representative. Support for Audits and Regulatory Inspections. Support Pharmacovigilance with various ad hoc deliverables or projects as needed. Provide coverage of dedicated adverse event reporting line during company business hours. Interact with internal and external