Manager, Drug Safety - ICSR Processes

Biogen; North Carolina; Hybrid; USD 116,000 - 155,000; Full time

Benefits offered by this job

Medical insurance

Dental/Vision

Paid time off

Holidays & time off

Job summary

Biogen is seeking a Manager, Drug Safety, ICSR Processes to define and improve global ICSR standards and data handling. You will serve as a subject matter expert ensuring quality, compliance, and inspection readiness across safety activities.

You will lead end-to-end process design, assessments, and UAT for safety system enhancements, collaborating with IT and cross-functional teams to translate regulatory requirements into practical workflows.

Qualifications

• Minimum 5 years of Drug Safety or Pharmacovigilance experience.
• Working knowledge of pharmacovigilance, ICSR processing, GCP, and GVP requirements.
• Experience authoring and maintaining pharmacovigilance procedures and process documentation.
• Ability to translate regulatory requirements into practical processes and system needs.
• Experience translating business needs into system requirements and supporting validation activities.

Responsibilities

• Define, design, write, maintain, and improve global ICSR processing standards and data handling conventions.
• Assess end-to-end ICSR processes to identify gaps, compliance risks, and improvement opportunities.
• Partner with Case Processing Oversight to analyze quality trends and drive improvements.
• Define and maintain business requirements for ICSR intake and case processing activities; support IT implementations.
• Conduct impact assessments and User Acceptance Testing for safety system enhancements.
• Support SOPs, job aids, training content, inspection readiness and audits.
• Lead process change management and training for new standards and procedures.
• Support cross-functional quality, compliance, and operational excellence initiatives.

Skills

Pharmacovigilance expertise

ICSR processing knowledge

Regulatory compliance

Process documentation

Cross-functional collaboration

UAT & validation

Education

Bachelor's degree in Nursing, Pharmacy, Life Sciences

Advanced degree in a relevant science

Job description

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

• 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.

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:

• 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

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 an