Biogen
Preference will be given to candidates who can work in a hybrid arrangement, with weekly presence onsite at our headquarters in Cambridge, MA. However, remote work may be available for highly qualified candidates residing within the United States.
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
Preferred Skills
Pay is based on location.
Job Level: Management
Additional Information
The base compensation range for this role is: $116,000.00-$155,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.