Aggregate Report Senior Scientist

Job Description

About This Role

Joining us as an Aggregate Report Senior Scientist, you will be a key member of the Safety Surveillance and Aggregate (SSA) Reports team within Global Safety and Regulatory Sciences (GSRS). In this role, you will be responsible for managing the processes for all aggregate reports, including PSURs, DSURs, PADERs, and local reports.

As a subject matter expert on global pharmacovigilance (PV) reporting requirements, you will collaborate with internal and external stakeholders, responding to safety queries, reviewing and supporting the authoring of medical and scientific safety information. You will work closely with vendors, vendor oversight teams, and quality management to ensure the highest standards in PV documentation. Additionally, you will contribute to process improvement initiatives and work cross-functionally to implement best practices in global safety compliance.

What You’ll Do

• Project manage and author aggregate safety reports (PSURs, DSURs, PADERs, local reports) alongside the PV Scientist Lead.
• Act as a subject matter expert on global safety regulations and company pharmacovigilance policies.
• Lead and coordinate responses to safety-related queries from regulatory authorities.
• Maintain and update the Aggregate Reports Master Schedule and oversee worldwide pharmacovigilance legislation requirements.
• Support and drive process improvements to enhance compliance, efficiency, and consistency in aggregate reporting.
• Collaborate with safety teams, clinical development, medical affairs, regulatory teams, and external vendors to ensure high-quality pharmacovigilance practices.
• Oversee and mentor junior Aggregate Reports Scientists, providing guidance on safety reporting best practices.

Who You Are

You are an experienced pharmacovigilance professional with strong expertise in aggregate safety report writing and safety signal management. You have a keen eye for detail and can interpret and present complex scientific and medical data clearly. You thrive in a collaborative environment, working cross-functionally to drive compliance and process improvements.

Qualifications

Required Skills

• Bachelor's degree in biological or natural sciences (Advanced degree preferred – MSc, PhD, MPH, PharmD, etc.).
• Significant and proven pharmacovigilance experience, with expertise in authoring aggregate safety reports and signal management.
• Strong analytical skills with the ability to interpret and present medical and scientific data.
• Knowledge of global pharmacovigilance regulations and reporting requirements.
• Experience working with safety databases and common data processing software (Excel, PowerPoint, Microsoft Word, Business Objects).
• Excellent organizational and teamwork skills, with the ability to work cross-functionally in a fast-paced environment.

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.