Safety Aggregate Reporting Manager

As a Safety Aggregate Reporting Manager, you will act as a stand-alone global functional lead for Safety Aggregate Report and Analytics (SARA) Center deliverables. Your responsibilities will include leading, authoring, and finalizing various aggregate reports such as PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, ACOs, line listings, and responding to regulatory inquiries. You will also be involved in literature surveillance, signal management activities, and benefit risk management documents. In this role, you will play a key role in setting up, implementing, and leading safety management teams for post-marketing and clinical trial projects. You will be responsible for overseeing signal detection activities, performing signal validation and evaluation analyses, and ensuring timely identification and characterization of risks. Additionally, you will maintain compliance, prepare metrics and KPIs, and present at audits and inspections. As a Safety Aggregate Reporting Manager, you will provide training to SARA staff, perform quality checks on deliverables, and ensure the quality of final deliverables to clients and regulatory authorities. You will also offer consultative guidance to internal and external stakeholders on SARA deliverables and act as a mentor and coach to project team staff. Your role will involve interfacing with clients and collaborating with various functional groups within Lifecycle Safety and other business units, including Regulatory Affairs Reporting (RR) and Real World Late Phase (RWLP). Overall, your expertise and leadership will be crucial in ensuring the successful delivery of Safety Aggregate Reports and Analytics.,