Manager, Drug Safety - ICSR Processes
Biogen
Summary
The Manager, Drug Safety, ICSR Processes is responsible for defining, designing, maintaining, and continuously improving global Individual Case Safety Report (ICSR) process standards, conventions, and procedural documentation across clinical and post-marketing safety activities. This role serves as a subject matter expert for ICSR processes, ensuring quality, compliance, inspection readiness, and effective use of pharmacovigilance systems supporting global safety operations.
Job description
About This Role
The Manager, Drug Safety, ICSR Processes is responsible for defining, designing, maintaining, and continuously improving global Individual Case Safety Report (ICSR) process standards, conventions, and procedural documentation across clinical and post-marketing safety activities. This role serves as a subject matter expert for ICSR processes, ensuring quality, compliance, inspection readiness, and effective use of pharmacovigilance systems supporting global safety operations.
What You Will Do
- Define, design, write, maintain, and improve global case processing standards, processes, and data handling conventions.
- Assess end-to-end ICSR processes to identify gaps, inefficiencies, compliance risks, and improvement opportunities.
- Partner with Case Processing Oversight to analyze quality trends and drive continuous improvement initiatives.
- Define and maintain business requirements for ICSR intake and case processing activities and support implementation with systems and IT teams.
- Conduct impact assessments and User Acceptance Testing (UAT) for safety system enhancements and changes.
- Support SOPs, job aids, training content, inspection readiness activities, audits, and health authority interactions.
- Lead process change management, communications, and training related to new or revised standards and procedures.
- Support cross-functional quality, compliance, and operational excellence initiatives.
Who You Are
You are a pharmacovigilance professional with experience in ICSR processing, global safety regulations, and process management who is passionate about driving quality, compliance, and operational excellence. You are skilled at translating complex regulatory and business requirements into practical processes, procedures, training, and system solutions while building strong partnerships across safety, quality, business, and technology functions. You are a proactive problem-solver with strong organizational and communication skills who thrives in a dynamic environment and is committed to continuous improvement, inspection readiness, and supporting patient safety.
Required Skills
- Bachelor's degree in Nursing, Pharmacy, Life Sciences, or related health discipline.
- Minimum 5 years of Drug Safety or Pharmacovigilance experience in pharmaceutical, biopharmaceutical, or CRO environments.
- Working knowledge of pharmacovigilance, ICSR processing, GCP, and GVP requirements.
- Experience authoring and maintaining pharmacovigilance procedures and process documentation.
- Ability to interpret regulatory requirements and assess operational impacts.
- Experience translating business needs into system requirements and supporting validation activities.
Preferred Skills
- Experience supporting safety system enhancements and UAT activities.
- Inspection readiness, audit support, and regulatory interaction experience.
- Experience working with cross-functional global project teams.
- Advanced degree in a relevant scientific discipline.
Requirements
- Bachelor's degree in Nursing, Pharmacy, Life Sciences, or related health discipline
- Minimum 5 years of Drug Safety or Pharmacovigilance experience in pharmaceutical, biopharmaceutical, or CRO environments
- Working knowledge of pharmacovigilance, ICSR processing, GCP, and GVP requirements
- Experience authoring and maintaining pharmacovigilance procedures and process documentation
- Ability to interpret regulatory requirements and assess operational impacts
- Experience translating business needs into system requirements and supporting validation activities
Benefits
- Medical, Dental & Vision
- Life Insurance
- Fitness & Wellness Programs
- Short- & Long-Term Disability
- 15 Days Paid Vacation
- End-of-Year Shutdown
- 12 Paid Holidays
- 80 Hours Sick Time
- Paid Maternity & Parental Leave
- 401(k) Matching
- Employee Stock Purchase Plan
- Tuition Reimbursement
- Employee Resource Groups
Company overview
Founded in 1978, Biogen is a leading global biotechnology company headquartered in Cambridge, Massachusetts, specializing in the development and commercialization of innovative therapies for serious neurological and neurodegenerative diseases. As one of the oldest independent biotechnology companies in the United States, Biogen has established itself as a pioneer in neuroscience, focusing on difficult-to-treat conditions where few or no treatment options exist. The company's portfolio includes groundbreaking treatments for multiple sclerosis, spinal muscular atrophy, Alzheimer's disease, ALS, and Friedreich's ataxia. With approximately 7,000 employees worldwide, Biogen operates through a global network that includes research and development hubs in Cambridge, Research Triangle Park in North Carolina, and South San Francisco, along with world-class manufacturing facilities in the United States and Switzerland. The company's commitment to scientific innovation is demonstrated by its Nobel Prize-winning founders and its receipt of the U.S. National Medal of Technology and Innovation. Biogen's patient-centric approach drives its mission to deliver transformative medicines that improve lives while creating sustainable value for shareholders and communities.