Manager, Aggregate Reports Scientist

About the position

As a Manager, Aggregate Reports Scientist within the Safety Surveillance and Aggregate Reports team of Global Safety and Regulatory Sciences, you will spearhead the end to end management of all aggregate reports, including PSURs, DSURs, PADERs, and local reports. Your expertise in aggregate reporting safety requirements will establish you as a subject matter expert, both within the Pharmacovigilance (PV) Scientist team and across Biogen. You will handle safety inquiries from various stakeholders, contribute to medical and scientific safety information, and engage in vendor and quality management collaborations. Your role is pivotal in driving initiatives for process refinement and ensuring compliance with global PV regulations. By joining our team, you will have the opportunity to contribute to a structure that fosters efficiency and consistency, ultimately enhancing patient safety and product stewardship.

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.

Requirements

• Bachelor’s Degree, preferably in a biologic or natural science. Advanced degree (MSc, PhD, MPH, PharmD, etc.) preferred.
• 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.

Nice-to-haves

• 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