About This RoleThis role reports into the Head of Aggregate Reports and will be part of the Safety Surveillance and Aggregate Reports (SSA) team. The Associate Director, Pharmacovigilance Scientist is responsible for managing the processes for all Aggregate Reports such as PSURs, DSURs, PADERs and local reports.The Associate Director will be the subject matter expert on Aggregate Reports safety requirements worldwide and lead independently all aspects of the production of an Aggregate Safety Report, including responses to safety questions from health authorities.This role leads independently initiatives for process improvement and efficiencies, and collaborates with stakeholders to develop, implement and maintain processes that are compliant with global PV regulations for Aggregate Safety Reports.There will be close collaboration with vendors, SSA vendor oversight team, and with the SSA Quality Management team to ensure high quality standards of the Aggregate Safety Reports.What You’ll DoLead independently and collaboratively all aspects of substantive projects including authoring aggregate safety reports and responses to regulatory agency requests.Serve as a subject matter expert on relevant safety requirements, company policies/procedures related to pharmacovigilance activities, as well as in-depth Aggregate Reports knowledge. Serve as example for behaviors that lead to high quality outputs.Responsible for the Aggregate Reports Master Schedule and worldwide legislation overview.Identify process non-compliance, gaps or inefficiencies and lead initiatives for process improvement, implements and maintains processes. Manage corrective actions when non-compliances are identified.Oversee and mentor PV Scientist staff.Who You AreYou are curious and have an analytical mind. You are enthusiastic and thrive working in a highly collaborative team. You enjoy working with medical scientific data sets to provide well written conclusions. You do not shy away from providing suggestions for process improvements. You enjoy guiding stakeholders in current processes or legislative requirements.
