Manager, Drug Safety - ICSR Processes

Biogen; Cambridge (MA); Hybride; USD 122 000 - 163 000; Plein temps

Avantages offerts par ce poste

Medical/Dental/Vision/Life

Fitness reimbursement

Disability insurance

Paid vacation days

Holidays & PTO

Maternity/Parental Leave

401(k) matching

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Résumé du poste

Biogen in Cambridge, MA is seeking a Manager, Drug Safety, ICSR Processes to define and improve global ICSR standards and documentation. This role emphasizes quality, inspection readiness, and collaboration with Case Processing Oversight and ICSR Systems to translate requirements into tech solutions.

The position offers a hybrid work arrangement with weekly onsite presence and a focus on continuous process improvement, training, and audits to ensure safety system effectiveness across global

Qualifications

• Bachelor’s degree in Nursing, Pharmacy, Life Sciences, or related health discipline.
• At least 4 years’ experience in Drug Safety or Pharmacovigilance in pharma/biotech/CRO.
• Knowledge of pharmacovigilance, ICSR processing, GCP, and GVP requirements.
• Experience writing pharmacovigilance procedures and process documentation.
• Ability to translate regulatory requirements into operational impact.

Responsabilités

• Define and improve global ICSR processing standards and data conventions.
• Assess end-to-end ICSR processes for gaps and compliance risks.
• Collaborate with Case Processing Oversight for quality improvement.
• Define business requirements for ICSR intake and processing; support IT.
• Lead or perform UAT for safety system enhancements.
• Support audits, inspections, and health authority interactions.

Connaissances

Pharmacovigilance

ICSR processing

GCP knowledge

GVP knowledge

Regulatory interpretation

System requirements

Formation

Bachelor's degree in Nursing, Pharmacy, Life Sciences

Description du poste

This role is based in Cambridge, MA and follows a hybrid work arrangement with weekly onsite presence.

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. 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 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, 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.

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 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.

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.

Job Level: Management

Additional 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.

Benefits

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 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.

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.