Manager, Drug Safety - ICSR Processes
About The Position
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. The role serves as a subject matter expert for ICSR processes, supporting quality, compliance, inspection readiness, and effective use of pharmacovigilance systems in global safety operations. It partners with Case Processing Oversight to strengthen quality and compliance and with ICSR Systems to translate business requirements into technology solutions. The position leads process improvement and change management, maintains ICSR business requirements and procedural documentation, supports safety-system implementation and testing, and develops and delivers training. It also supports assessment of evolving global pharmacovigilance requirements and serves as an ICSR Processes subject matter expert during audits, inspections, and health authority interactions. The role is based in Cambridge, Massachusetts, with a hybrid arrangement requiring weekly onsite presence. The base compensation range is $122,000 to $163,250. Regular employees may be eligible for short- and long-term incentives, including cash bonuses and equity incentive opportunities.
Requirements
- Bachelor's degree in Nursing, Pharmacy, Life Sciences, or a related health discipline.
- Minimum of 4 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.
Nice To Haves
- An advanced degree in a relevant discipline may be considered in combination with relevant industry experience.
- Experience supporting safety-system enhancements and UAT activities.
- Inspection-readiness, audit-support, and regulatory-interaction experience.
- Experience working with cross-functional global project teams.
Responsibilities
- 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 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 assessments of new and evolving global pharmacovigilance requirements and their impacts 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.
- Serve as an ICSR Processes subject matter expert 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.
Benefits
- Short- and long-term incentives, including cash bonus and equity incentive opportunities, for eligible regular employees.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- Life insurance.
- Fitness and wellness programs, including fitness reimbursement.
- Short- and long-term disability insurance.
- At least 15 days of paid vacation and end-of-year shutdown time off from December 26 through December 31.
- Up to 12 company-paid holidays and 3 paid days off for Personal Significance.
- 80 hours of sick time per calendar year.
- Paid maternity and parental leave.
- 401(k) program with company-matched contributions.
- Employee stock purchase plan.
- Tuition reimbursement of up to $10,000 per calendar year.
- Employee Resource Groups participation.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
