Lead PV Aggregate Reports Scientist

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with match

Paid time off

Bonuses and equity opportunities

Job summary

Biogen is seeking a PV Aggregate Reports Scientist to lead the authoring and program management of global safety reports such as PSURs, DSURs, and PADERs. The role requires expert pharmacovigilance knowledge and cross-functional collaboration within Safety, Clinical Development, and vendor oversight teams.

You will interpret complex safety data, respond to regulatory inquiries, and help drive process improvements and consistency across product groups.

Qualifications

• Bachelor's Degree in biologic or natural science.
• Minimum 5 years of pharmacovigilance experience, including aggregate safety reports writing 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 common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects).
• Knowledge of common safety database systems.

Responsibilities

• Lead and manage all aspects of aggregate safety report authoring and project management.
• Serve as SME on safety requirements in cross-functional forums.
• Support the Aggregate Reports Master Schedule and stakeholder reviews.
• Review worldwide regulations and provide impact assessments.
• Assist in writing responses to safety questions from regulators.
• Contribute to process improvements and signal management.
• Support implementation of new and existing processes.
• Interpret and present scientific data clearly in writing and speaking.
• Collaborate with Safety, Clinical Development, and other teams.
• Apply clinical judgment to interpret case information for staff guidance.

Skills

Pharmacovigilance

Aggregate safety reports

Project management

Regulatory knowledge

Communication skills

Organizational skills

Data interpretation

Education

Bachelor's degree in biological or natural science

Advanced degree (MSc/PhD/MPH/PharmD)

Tools

Excel

PowerPoint

Microsoft Word

Business Objects

Job description

Biogen is seeking a PV Aggregate Reports Scientist to lead the authoring and program management of global safety reports such as PSURs, DSURs, and PADERs. The role requires expert pharmacovigilance knowledge and cross-functional collaboration within Safety, Clinical Development, and vendor oversight teams.

You will interpret complex safety data, respond to regulatory inquiries, and help drive process improvements and consistency across product groups.