Safety Aggregate Reporting Manager

As a Safety Aggregate Reporting Manager, you will act as a stand-alone global functional lead, utilizing your 7+ years of experience in Safety Aggregate Report and Analytics (SARA) Center deliverables. Your responsibilities will include: - Leading, authoring, and finalizing aggregate reports such as PBRERs/PSURs, DSURs, PADERs, RMPs, REMS, ACOs, line listings, and responding to regulatory agency inquiries. - Conducting ongoing literature safety surveillance for marketed and investigational products, identifying ICSRs, evaluating events, and contributing to literature deliverables for aggregate reports and signal management activities. - Serving as a Signal Management Lead on large post-marketing and clinical trial projects, overseeing signal detection activities, and performing signal validation and evaluation analyses. - Ensuring compliance, preparing metrics, presenting at audits and inspections, and providing training to SARA staff for qualification on SARA deliverables. - Mentoring and coaching project team staff and direct line reports, and offering consultative guidance to stakeholders on SARA deliverables. You will also be responsible for the quality of the final SARA deliverables to clients, regulatory authorities, and IQVIA regulatory reporting (RR). Additionally, you will interface with clients and other functional groups within Lifecycle Safety and other business units. If there are any additional details about the company in the job description, please provide it for inclusion in the job description.,