Manager, Drug Safety – ICSR Processes

Biogen

. Define, design, write, maintain, and improve global case processing standards, processes, and data handling conventions .

Posted 10/22/2026full-timeCambridge • Massachusetts • United StatesMid-LevelSenior💰 $122,000 - $163,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Drug Safety and Pharmacovigilance, with a strong focus on ICSR processing, regulatory compliance, and process improvement. Capable of leading cross-functional teams and delivering training while ensuring adherence to global standards and best practices.

Highest-signal resume keywords

Drug Safety ExperiencePharmacovigilance KnowledgeICSR ProcessingRegulatory InteractionProcess Improvement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

ICSR ProcessingPharmacovigilance ProceduresRegulatory Requirements InterpretationUser Acceptance TestingImpact AssessmentProcess DocumentationTraining DevelopmentChange ManagementQuality ComplianceOperational Excellence

Soft Skills

Cross-Functional CollaborationCommunication SkillsProblem-SolvingLeadership

Industry Keywords

GCPGVPAudit SupportInspection ReadinessHealth Authority InteractionsPharmaceuticalBiopharmaceuticalCROContinuous ImprovementProcess Standards

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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 process improvements
Partner with Case Processing Oversight to identify quality trends and process deficiencies and support remediation, retraining, and continuous improvement
Define and maintain business requirements for ICSR intake and case processing and support implementation with systems and IT teams
Conduct impact assessments and User Acceptance Testing 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 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

Requirements

What you’ll need

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
Experience supporting safety system enhancements and UAT activities
Inspection readiness, audit support, and regulatory interaction experience
Experience working with cross-functional global project teams

Benefits

Comp & perks

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
Short term and long-term incentives, including cash bonus and equity incentive opportunities