Sr. Manager, Aggregate Reports Scientist

Job Description

About This Role
As a Senior Manager, Aggregate Report Scientist, you will be an integral part of the Safety Surveillance and Aggregate (SSA) Reports team. In this pivotal role, you will oversee the pharmacovigilance processes for all aggregate reports, including PSURs, DSURs, PADERs, and local reports, for a designated product or group of products. Your expertise will contribute significantly to managing signal activities, regulatory requests, literature reviews, and clinical trial safety undertakings. The value you bring to the team will be reflected in your role as a subject matter expert, offering guidance on safety requirements globally and ensuring high-quality standards. Collaborating with cross-functional groups, you will work on initiatives for process improvement, upholding compliance with global PV regulations. Your position will not only enhance the efficiency and consistency of our safety practices but also serve as a cornerstone in the development of our product safety profiles within the overarching business structure.

What You’ll Do

• 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.

Who You Are
You are a visionary with a keen eye for detail and a passion for scientific rigor. With your advanced understanding of medical concepts, you are adept at presenting complex data with clarity and precision. As a collaborative team player, you engage effectively within diverse teams, including Safety, Clinical Development, and Regulatory Affairs, and you thrive when working with external partners. 

Qualifications

• 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.

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.