Global PV Reports Scientist (PSUR/DSUR) - Remote/EST

Real Staffing Group; Cambridge (MA); Híbrido; USD 90 000 - 128 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Retirement plans

Life and disability insurance

Paid leave

Resumo da oferta

Biogen in Cambridge, MA is seeking a PV Aggregate Report Scientist on a 1-year contract with a hybrid arrangement (2-3 days onsite in Cambridge or fully remote for EST hours). Start date 11/2/2026.

The role supports global PV aggregate reports (PSURs, DSURs, PADERs) and maintains the master schedule. The candidate will lead project teams, perform regulatory reviews, and drive process improvements to ensure robust safety documentation.

Qualificações

• Bachelor's degree in biological or natural sciences required; advanced degree preferred.
• 5+ years' pharmacovigilance experience with aggregate safety report writing and signal management.
• Strong ability to interpret data and communicate complex safety information.

Responsabilidades

• Lead and manage aggregate report projects and the Aggregate Reports Master Schedule.
• Review regulatory changes and assess impact on safety reporting.
• Collaborate with vendors and Quality Management to ensure high-quality PV documentation.

Conhecimentos

PSUR

DSUR

Aggregate Reporting

Signal Detection

Pharmacovigilance

Safety report writing

Formação académica

Bachelor's in Biological/Natural Sciences

Ferramentas

Excel

PowerPoint

Word

Business Objects

Descrição da oferta de emprego

Biogen in Cambridge, MA is seeking a PV Aggregate Report Scientist on a 1-year contract with a hybrid arrangement (2-3 days onsite in Cambridge or fully remote for EST hours). Start date 11/2/2026.

The role supports global PV aggregate reports (PSURs, DSURs, PADERs) and maintains the master schedule. The candidate will lead project teams, perform regulatory reviews, and drive process improvements to ensure robust safety documentation.