Senior Manager, Aggregate Reports Scientist

Summary

Join Biogen's Safety Surveillance and Aggregate (SSA) Reports team as a Senior Manager, Aggregate Report Scientist. You will oversee pharmacovigilance processes for aggregate reports (PSURs, DSURs, PADERs, and local reports), manage signal activities, regulatory requests, and literature reviews. Your expertise in global safety requirements and process improvement will be crucial. You will collaborate with cross-functional teams, mentor junior staff, and represent the team in various forums. This role requires a strong scientific background, experience in aggregate safety reporting, and excellent communication and leadership skills. The position offers the opportunity to significantly impact product safety profiles and contribute to a life-changing mission.

Requirements

• Bachelor’s Degree in biologic or natural science or advanced degree (MSc, PhD, MPH, PharmD, etc.)
• Minimum 8 years Pharmacovigilance experience, including experience in aggregate safety reports writing and safety signal management
• Expertise in management and authoring of aggregate data reports
• Proficiency in analyzing, interpreting, and presenting scientific and medical data both verbally and in writing
• Demonstrated ability to work collaboratively in a team environment and with external partners
• Experience in leading and conducting significant projects independently or in a team setting
• Strong communication skills in cross-functional forums
• Proven capability to manage and oversee substantial projects, including signaling and authoring of data reports
• Strong organizational skills with the ability to independently prioritize and manage tasks
• Basic knowledge of data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects) and safety database systems

Responsibilities

• Manage the project planning and authoring of aggregate safety reports such as PSURs, DSURs, PADERs, and local reports, in close collaboration with the PV scientist Lead
• Serve as a subject matter expert on global safety requirements, company policies, and procedures related to pharmacovigilance activities
• Implement and oversee process improvement initiatives, contributing to the maintenance of compliant and efficient operations
• Maintain the Aggregate Reports Master Schedule, ensuring compliance with worldwide legislation and facilitating stakeholder reviews
• Coordinate with the PV Scientist lead to author comprehensive responses to safety inquiries from regulatory authorities
• Spearhead initiatives aimed at enhancing the consistency of aggregate reporting, clinical trial safety oversight, signal management, and ad hoc safety question responses
• Independently and collaboratively lead substantive projects, such as the authoring of aggregate data reports and regulatory requests, while providing mentorship to less experienced PV Scientist staff
• Represent the team in cross-Safety and cross-functional forums, effectively communicating processes and project outcomes
• Manage substantive projects like signaling and authoring of aggregate data reports, ensuring successful completion by direct reports
• Utilize clinical judgment to interpret case information and guide staff in clinical evaluation