Safety Aggregate Report Specialist 2

As a Safety Aggregate Report Specialist, you will be responsible for applying your knowledge and expertise in Safety Aggregate Report and Analytics (SARA) Center deliverables. Your essential functions will include: - Serving as the principal owner of the SARA deliverables, ensuring their completion in compliance with all applicable service level agreements (SLA). - Leading, authoring, and finalizing aggregate reports such as PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings. - Authoring responses to regulatory agency/Pharmacovigilance Risk Assessment Committee (PRAC) inquiries. - Conducting ongoing literature safety surveillance for marketed and investigational products and assisting in the identification of ICSRs from literature. - Acting as Signal Management Lead on post-marketing and clinical trial projects, setting up signaling strategies, and conducting signal detection activities. - Leading/authoring safety responses to regulatory agencies/PRAC and justifications to support labeling documents. - Interface with clients and other functional groups within Lifecycle Safety and other business units. - Participating in internal and external audits and inspections. - Contributing to the achievement of departmental goals and ensuring adherence to all necessary SOPs. - Serving as the interface between the global project lead and the working team. - Providing mentorship and training to less experienced resources. - Providing regular reports to project and department management on project metrics, SOW changes, client requests or concerns. - Participating in project review meetings with management. - Supporting and contributing to technology/innovation activities. Qualifications required for this role include: - Bachelor's Degree in a Scientific or Healthcare discipline. - 3-5 years of relevant work experience preferred. You will play a crucial role in ensuring the timely and accurate completion of safety aggregate reports and analytics as well as contributing to the overall success of the department and project.,