Manager, Aggregate Reports Scientist

Summary

Join Biogen's Global Safety and Regulatory Sciences team as a Manager, Aggregate Reports Scientist. You will lead the end-to-end management of aggregate safety reports (PSURs, DSURs, PADERs, and local reports), serving as a subject matter expert. Responsibilities include authoring reports, overseeing schedules, reviewing global legislation, responding to safety inquiries, and driving process improvements. This remote position requires a Bachelor's degree in a biological or natural science (advanced degree preferred), 5+ years of pharmacovigilance experience, and 5+ years in aggregate safety report writing and safety signal management. You will need strong analytical, organizational, and teamwork skills. Biogen offers a competitive salary, comprehensive benefits, and opportunities for professional growth.

Requirements

• Bachelor’s Degree, preferably in a biologic or natural science
• Minimum of 5 years of Pharmacovigilance experience and 5 years of experience in aggregate safety reports writing and safety signal management
• Expertise in management and authoring of aggregate data reports
• Demonstrated ability to understand, interpret, analyze, and present scientific and medical data
• Proven teamwork capabilities, with effective interaction in a multi-disciplinary environment
• Clinical judgment skills for guiding staff and interpreting case information
• Familiarity with clinical trial safety regulations and post-marketing safety regulations
• Strong organizational skills and the ability to work independently with minimal supervision
• Proficiency in common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects) and knowledge of common safety database systems

Responsibilities

• Lead and manage the authoring and project management of aggregate safety reports such as PSURs, DSURs, PADERs, and local reports, both independently and collaboratively
• Act as a subject matter expert on safety requirements, representing processes in cross-functional forums and advising on company policies/procedures related to PV activities
• Oversee the Aggregate Reports Master Schedule, including production, updates, and stakeholder reviews
• Review global legislation related to aggregate reports and assess their impact on operations
• Author responses to safety questions from regulatory authorities in collaboration with the PV Scientist team and other stakeholders
• Drive initiatives aimed at improving process efficiency and consistency in aggregate reporting, signal management, and clinical trial safety oversight
• Implement and maintain new processes that align with global PV regulations and improve cross-program practices

Preferred Qualifications

• Advanced degree (MSc, PhD, MPH, PharmD, etc.) preferred
• Experience in leading cross-functional teams and projects
• Proven track record of process improvement in a Pharmacovigilance setting

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation