Hybrid in Cambridge, MA (2-3 days on-site) Must be able to work on a W2 Key Responsibilities Aggregate Report Management: Lead and conduct all aspects of aggregate safety reporting projects, including the authoring and project management of PSURs, DSURs, PADERs, and local reports, independently or collaboratively. Subject Matter Expertise: Serve as an expert on relevant safety requirements, company policies, and aggregate reporting processes. Represent and articulate these processes in cross-Safety and cross-functional forums. Schedule & Regulatory Oversight: Support the Aggregate Reports Master Schedule, including production, updates, and stakeholder reviews. Conduct worldwide legislation reviews related to aggregate reporting and provide impact assessments. Health Authority Responses: Support the authoring of responses to safety inquiries from regulatory authorities in partnership with PV Scientists and key stakeholders. Cross-Functional Collaboration: Partner with Safety, Clinical Development, Medical Affairs, Clinical Operations, Regulatory, Quality Management, vendors, and external colleagues. Vendor & Quality Oversight: Work closely with vendors, vendor oversight, and Quality Management teams to maintain high-quality standards across PV documents. Process Optimization: Drive process improvement initiatives to enhance consistency across aggregate reporting, signal management, clinical trial safety oversight, and ad hoc safety responses. Process Implementation: Maintain existing procedures and support the implementation and rollout of new pharmacovigilance processes. Respond to safety questions from internal and external stakeholders while reviewing and supporting the authoring of medical and scientific safety information. Essential Skills & Qualifications Ability to understand, interpret, analyze, and clearly communicate scientific and medical data, both verbally and in writing. Strong understanding of medical concepts and terminology. Demonstrated ability to work cross-functionally across Safety, Clinical Development, Medical Affairs, Clinical Operations, Regulatory, and external partners. Ability to apply clinical judgment when interpreting case information and provide guidance on case data evaluation. Knowledge of pharmacovigilance, drug development, clinical trial safety regulations, and post-marketing safety regulations. Familiarity with case processing, expedited reporting, safety databases, aggregate reporting, and safety signal management. Strong organizational and prioritization skills with the ability to work independently with minimal supervision. Basic proficiency with Excel, PowerPoint, Word, and Business Objects. Familiarity with common safety database systems. Education & Experience Bachelor’s degree in biological or natural sciences required. Advanced degree such as an MSc, PhD, MPH, PharmD, or equivalent preferred. Minimum of 5 years of Pharmacovigilance experience. Direct experience with aggregate safety report writing required. Experience with safety signal management required. #J-18808-Ljbffr
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