Senior Manager, Global Patient Safety

Reporting to the Associate Director of Global Patient Safety (GPS), this position is responsible for the initial Intake of adverse event data (i.e., via PV Intake Tool, electronic, fax, etc.). They will lead the subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities, Collaborators and internal destinations in compliance with applicable global regulations (such as ICH-GCP, GVP VI) and contractual obligations. This role will lead a team responsible for Intake and ICSR submissions for the company product portfolio covering pre and post marketing activities, serving as ICSR Submission subject matter expert (SME) on running small to large sized studies/programs that are moderate to sophisticated in scope of work with minimal guidance. In this role, a typical day might include the following: Contributing to Intake responsibilities for Argus events, in addition to all aspects of ICSR submission start-up process Tracking and monitoring of ICSR timelines to ensure that submissions to regulatory agencies, Collaborators, internal destinations and contract research organizations (CROs) are aligned. Proactively investigating potential issues or noncompliance and raises trends and critical issues where appropriate to Management. Leading investigations of non-compliance issues and identification of root cause for late ICSR submissions. Addressing and Implementing appropriate corrective actions related to ICSR submission activities. Assisting in the management and oversight of ICSR transmissions between the PV Intake Tool and Argus database and from Collaborators to Argus database. Proactively identifying and leading continuous improvement/quality system initiatives through evaluation, development and roll out of process efficiencies applicable to all deliverables. Authoring new and updates existing SOPs and Working Instructions, and conducts related training.

• You have a minimum of Bachelor's Degree, Master's Degree preferred, in one of the life sciences or clinical research and/or licensed healthcare professional required.
• Previous experience in drug safety and safety reporting in pharmaceutical/biotech industry is required with minimum of 8 years.
• Able to independently and expertly identify, analyze, and problem solve complex issues and trends.
• We are looking for people with strong knowledge and understanding of clinical research process and global pharmacovigilance regulations, systems, and processes. Extensive knowledge of the adverse event lifecycle.