Senior Manager, Aggregate Report Scientist - Remote

Overview

As a Senior Manager, Aggregate Report Scientist, you will oversee the pharmacovigilance processes for all aggregate reports, contributing significantly to managing signal activities and ensuring compliance with global PV regulations.

In Short

• Manage project planning and authoring of aggregate safety reports.
• Serve as a subject matter expert on global safety requirements.
• Implement process improvement initiatives.
• Maintain the Aggregate Reports Master Schedule.
• Coordinate responses to safety inquiries from regulatory authorities.
• Lead projects related to aggregate data reports and regulatory requests.
• Represent the team in cross-functional forums.
• Utilize clinical judgment to guide staff in clinical evaluation.
• Mentor less experienced PV Scientist staff.
• Enhance consistency of aggregate reporting and safety oversight.

Requirements

• Bachelor’s Degree in biologic or natural science or advanced degree.
• Minimum 8 years of Pharmacovigilance experience.
• Expertise in authoring aggregate data reports.
• Proficiency in analyzing and presenting scientific data.
• Ability to work collaboratively in a team environment.
• Experience in leading significant projects.
• Strong communication skills.
• Organizational skills to manage tasks independently.
• Basic knowledge of data processing software.

Benefits

• Medical, dental, and life insurance.
• 401K participation and matching contributions.
• Vacation and end-of-year shutdown.
• Participation in Biogen’s LTI grants and incentive programs.