New · posted Nov 1
Biogen · Biotechnology
Manager, Drug Safety - ICSR Processes
- Cambridge, MA
- Hybrid
- Full-time
- Manager
The role
This role is based in Cambridge, MA and follows a hybrid work arrangement with weekly onsite presence.
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. This role partners closely with Case Processing Oversight to strengthen quality and compliance and with ICSR Systems to ensure business requirements are effectively translated into technology solutions.
What you need
Required Skills
- Bachelor's degree in Nursing, Pharmacy, Life Sciences, or related health discipline.
- Minimum 4 years of Drug Safety or Pharmacovigilance experience in pharmaceutical, biopharmaceutical, or CRO environments. An advanced degree in a relevant discipline may be considered in combination with relevant industry experience.
- 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.
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.
Preferred Skillsnice to have
- Experience supporting safety system enhancements and UAT activities.
- Inspection readiness, audit support, and regulatory interaction experience.
- Experience working with cross-functional global project teams.
Job Level: Management
What you'll 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, and compliance risks, and design and implement appropriate process improvements.
- Partner with Case Processing Oversight to identify quality trends and process deficiencies and support remediation, retraining, and continuous improvement activities.
- 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.
- Lead or support assessment of new and evolving global pharmacovigilance requirements and their impact on ICSR processes and standards.
- Lead the development and maintenance of ICSR procedural documentation, including SOPs, job aids, and related process documentation.
- Develop and deliver ICSR process training and serve as an ICSR Processes SME during audits, inspections, and health authority interactions.
- Lead process change management and communications to support adoption of new or revised standards and procedures.
- Support cross-functional quality, compliance, and operational excellence initiatives.
Pay and benefits
$122,000 – $163,250 a year
Employer providedAdditional Information
The base compensation range for this role is: $122,000.00-$163,250.00
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:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
Medical, dental, vision and life insurance
401(k) with company match
Employee stock purchase plan
Paid vacation, holidays and sick time
Paid maternity and parental leave
Tuition reimbursement up to $10,000 per year
Where you'll work
Cambridge, MAHybridOpen in Maps (opens in a new tab)
More jobs in Cambridge, MA
From the posting
About Biogen
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 Biogen.
Equal opportunity, accessibility and legal noticesBiogen's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 14% below the US median for Clinical Safety & Pharmacovigilance roles at this level.
This roleEmployer provided
Manager roles in Massachusetts6 roles publishing pay
Manager roles in the US26 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $122,000 | — | $163,250 |
| Massachusetts (middle half) | $154,750 | $169,250 | $175,125 |
| All US (middle half) | $151,000 | $165,750 | $179,875 |
This role: Biogen's own published range. Comparisons: the base pay employers published on open Clinical Safety & Pharmacovigilance roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Safety & Pharmacovigilance
The general path across 162 open Clinical Safety & Pharmacovigilance roles on Regulatory Jobs, with the titles they carry most. Not Biogen's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct9
- Collaboration and leadership9
- GMP and compliance7
- Documentation and SOPs5
- Quality systems and risk3
- Lab testing and methods1
- Validation and qualification1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Biogen on Regulatory Jobs
- 23
- Open roles
- 23
- Distinct roles
- 4
- Locations
By discipline
- Clinical12 52%
- Quality7 30%
- Regulatory4 17%
By level
- Director7 30%
- Senior & Principal7 30%
- VP & Executive4 17%
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Manager, Drug Safety - ICSR Processes at Biogen
Open until filled. $122K–$163K a year, employer provided.