PV Scientist

Overview

In this role you support pharmacovigilance by performing signal management and writing safety evaluations. You will contribute to aggregate report planning, respond to regulatory requests, and review safety literature. Depending on the product, you may lead or support PV activities, collaborating with clinical trial safety teams to ensure global regulatory compliance. This position underpins patient safety and Biogen’s reputation for excellence in biotech.

Responsibilities

• Collaborate on producing aggregate safety reports (PSURs, DSURs, Risk Management Plans)
• Facilitate signal management, track signals, and evaluate safety data for new signals
• Conduct safety literature reviews and coordinate data with other groups
• Work with Clinical Trial physicians and Global Safety Officers on investigational programs (protocol review, data analysis)
• Coordinate responses to safety questions from regulatory authorities
• Contribute to process improvement in aggregate reporting and signal management
• Serve as a Subject Matter Expert for global safety regulations and data analysis

Key requirements

• Bachelor in biologic or natural science or health care discipline
• Significant pharmacovigilance experience in pharma/biotech with signal detection experience OR significant medical device PMS experience
• Proficiency in interpreting and presenting scientific/medical data
• Strong collaboration and teamwork skills
• Ability to lead substantive projects independently and collaboratively
• Familiarity with pharmacovigilance and drug development regulations
• Strong organizational skills and task prioritization
• Basic knowledge of Excel, PowerPoint, Word, and Business Objects

• collaborative mindset
• analytical thinking
• strong communication
• pharmacovigilance and drug development regulations
• signal detection and safety data analysis
• safety database systems (preferred)

Full job description from WhatJobs. Apply for this role →