Senior PV Scientist — Lead Safety & Reports

Biogen; Cambridge (MA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) match

Stock purchase plan

Tuition reimbursement

Paid time off

Job summary

Biogen in Cambridge, MA is seeking a Senior Pharmacovigilance Scientist to lead safety signal management, author aggregate reports, review medical literature, and support PV activities in trials and on marketed products.

You will mentor staff, collaborate with Global Safety Officers, and ensure compliance with global safety regulations while sharing data across cross-functional teams in a dynamic biotech setting.

Qualifications

• Bachelor's or advanced degree in life sciences or related field.
• Significant PV experience with aggregate reports and signal management.
• Ability to interpret and present scientific data clearly.

Responsibilities

• Lead the signal management process including detection and safety decisions.
• Author signal evaluation reports and manage literature review for safety info.
• Respond to regulatory inquiries and lead AR management.
• Finalize PSURs/DSURs and other safety reports for products.
• Collaborate with Global Safety Officers and cross-functional teams.

Skills

Pharmacovigilance

Signal management

Literature review

Regulatory knowledge

Data analysis

Excel

Leadership

Education

Bachelor's or higher in life sciences

Tools

Microsoft Office

Job description

Biogen in Cambridge, MA is seeking a Senior Pharmacovigilance Scientist to lead safety signal management, author aggregate reports, review medical literature, and support PV activities in trials and on marketed products.

You will mentor staff, collaborate with Global Safety Officers, and ensure compliance with global safety regulations while sharing data across cross-functional teams in a dynamic biotech setting.