Lead PV Aggregate Reports Scientist

Biogen; Cambridge (MA); On-site; USD 122,000 - 163,000; Full time

Job summary

Biogen is seeking a PV Aggregate Reports Scientist to lead authoring and project management of pharmacovigilance aggregate safety reports, including PSURs, DSURs, PADERs, and local reports. You will serve as a subject matter expert on safety requirements and coordinate with vendors, QA, and cross-functional partners.

You will support the Master Schedule, perform worldwide legislation reviews, and assist in regulatory responses while driving process improvements and ensuring high-quality safety

Qualifications

• Bachelor’s Degree in biologic or natural science; 5+ years pharmacovigilance experience including aggregate safety reports writing and safety signal management; familiarity with PV and drug development regulations; strong organizational skills; basic data processing software knowledge (Excel, PowerPoint, Word, BO)

Responsibilities

• Lead and conduct all aspects of authoring and project management of aggregate safety reports.
• Serve as SME on safety requirements and pharmacovigilance activities in cross-functional forums.
• Support the Aggregate Reports Master Schedule; assist in production, updates and stakeholder reviews.
• Conduct worldwide legislation reviews related to aggregate reports and provide impact assessments.
• Assist in authoring responses to safety questions from regulatory authorities with stakeholders.
• Contribute to process improvement and consistency in aggregate reports and signal management.
• Interpret, analyze, and present scientific data clearly in verbal and written formats.
• Collaborate within the team and with Safety, Clinical Development, and other functions.
• Apply clinical judgment to interpret case information and guide staff.

Skills

Pharmacovigilance

Aggregate reports

Safety signal management

Excel

PowerPoint

Microsoft Word

Business Objects

Safety databases

Education

Bachelor’s Degree in biologic or natural science

Advanced degree (MSc, PhD, MPH, PharmD)

Tools

Safety database systems

Job description

Biogen is seeking a PV Aggregate Reports Scientist to lead authoring and project management of pharmacovigilance aggregate safety reports, including PSURs, DSURs, PADERs, and local reports. You will serve as a subject matter expert on safety requirements and coordinate with vendors, QA, and cross-functional partners.

You will support the Master Schedule, perform worldwide legislation reviews, and assist in regulatory responses while driving process improvements and ensuring high-quality safety