Manager, Drug Safety - ICSR Processes
$116k - $155kBiogen
Biogen seeks a Manager of Drug Safety focused on Individual Case Safety Report (ICSR) processes. This role defines and improves global safety standards, ensures regulatory compliance, and partners across functions to enhance pharmacovigilance operations supporting clinical and post-marketing activities.
Responsibilities
- Define, design, and maintain global ICSR processing standards, conventions, and data handling procedures
- Assess end-to-end ICSR workflows to identify gaps, risks, and continuous improvement opportunities
- Partner with Case Processing Oversight to analyze quality trends and drive enhancements
- Conduct impact assessments and User Acceptance Testing for safety system changes
- Lead process change management, training, and communications for new procedural standards
Requirements
- Bachelor's degree in Nursing, Pharmacy, Life Sciences, or related health discipline
- Minimum 5 years Drug Safety or Pharmacovigilance experience in pharmaceutical or biopharmaceutical settings
- Working knowledge of ICSR processing, GCP, and GVP regulatory requirements
- Experience authoring and maintaining pharmacovigilance procedures and documentation
- Ability to interpret regulatory requirements and assess operational impacts
- Experience translating business needs into system requirements and supporting validation
Compensation: $116,000–$155,000 base
Vacancy posted 6 days ago
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