PV Drug Safety - Aggregate Reporting

Job Title: Drug Safety Consultant Location: Remote EST Duration: 12 months with possible extension Pay rate: $79.61/hr. on W2 Job Description: The PV Aggregate Reports Scientist is part of the Safety Surveillance and Aggregate (SSA) Reports team and is responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs, and local reports). In this role, you will: Serve as a subject matter expert on worldwide aggregate reporting safety requirements for the PV Scientist team, Safety, and cross-functional partners. Respond to safety questions from internal and external stakeholders while reviewing and supporting the authoring of medical and scientific safety information. Work closely with vendors, vendor oversight, and Quality Management teams to ensure high-quality standards across PV documents. Support process improvement initiatives in collaboration with PV Sciences and cross-functional groups to develop, implement, and maintain compliant, efficient, and consistent global PV processes. Key Responsibilities: Aggregate Report Management: Lead and conduct all aspects of substantive projects, including the authoring and project management of PSURs, DSURs, PADERs, and local reports independently or collaboratively. Subject Matter Expertise: Act as an expert on relevant safety requirements, company policies, and aggregate reporting knowledge; represent and articulate processes in cross-Safety and cross-functional forums. Schedule & Regulatory Oversight: Suppo