Lead PV Aggregate Reports Scientist

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

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness program

Paid vacation with year-end shutdown

401(k) with company match

Tuition reimbursement

Job summary

Biogen, Inc. is seeking a PV Aggregate Reports Scientist to lead authoring and project management of worldwide aggregate safety reports within the SSA team.

You will act as a subject matter expert on safety requirements, interact with cross-functional partners, and support master scheduling, with emphasis on compliance and process improvements. You will review safety information, respond to regulatory inquiries, and help ensure high-quality, well-documented outputs across PSURs, DSURs, PADERs,

Qualifications

• Bachelors degree in biologic or natural science.
• Minimum 5 years pharmacovigilance experience, including aggregate safety reports and safety signal management.
• Familiarity with pharmacovigilance and drug development, including clinical trial and post-marketing safety regulations.
• Strong organizational skills and ability to prioritize independently.
• Basic knowledge of Excel, PowerPoint, Word, and Business Objects.
• Knowledge of common safety database systems.

Responsibilities

• Lead and conduct, independently and/or collaboratively, all aspects of authoring and project management of aggregate safety reports.
• Serve as a subject matter expert on safety requirements and pharmacovigilance activities, representing processes in cross-functional forums.
• Support the Aggregate Reports Master Schedule, including 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 in collaboration with stakeholders.
• Contribute to process improvement initiatives and consistency regarding aggregate reports and signal management.
• Support the implementation and maintenance of new and existing processes.
• Interpret, analyze, and present scientific and medical data clearly in both verbal and written formats.
• Collaborate effectively within the team and with external colleagues across Safety, Clinical Development, and other functions.
• Apply clinical judgment to interpret case information and guide staff in interpretation.

Skills

Pharmacovigilance

Aggregate safety reports

Safety signal management

Cross-functional collaboration

Organizational skills

Education

Bachelors degree in biological or natural science

Tools

Excel

PowerPoint

Microsoft Word

Business Objects

Job description

Biogen, Inc. is seeking a PV Aggregate Reports Scientist to lead authoring and project management of worldwide aggregate safety reports within the SSA team.

You will act as a subject matter expert on safety requirements, interact with cross-functional partners, and support master scheduling, with emphasis on compliance and process improvements. You will review safety information, respond to regulatory inquiries, and help ensure high-quality, well-documented outputs across PSURs, DSURs, PADERs,