Manager, Drug Safety - ICSR Processes
优先考虑可以在**混合式**安排工作的候选人，每周都会在我们位于美国剑桥 (MA) 的总部现场。然而，对于居住在美国的高资格候选人来说，远程工作可能可供使用。**关于这一职位** ICSR 过程经理负责定义，设计，维护和不断改善全球**个人案例安全报告 (ICSR) **程序标准，公约以及临床和营销后安全活动中的程序文档。这一职位是 ICSR 流程的专家，确保质量，合规性，检查准备性和有效利用支持全球安全运营的药物监督系统。**What You Will Do** - 定义，设计，写作，维护和改善全球案例处理标准，过程和数据处理公约。-评估端到端 ICSR 进程以确定漏洞，效率低下，合规风险和改进机会。- 与案件处理监管合作分析质量趋势并推动持续改进倡议。- 确定和维护 ICSR 接入和处理案例活动的业务要求，并支持系统和 IT 团队实施。- 对安全系统改进和变化进行影响评估和用户接受性测试 (UAT). - 支持 SOP,工作辅助工具，培训内容，检查准备活动，审计和卫生当局互动。- 领导与新或修订标准和程序有关的过程变革管理，沟通和培训。- 支持跨职能质量，合规和运营卓越举措。**你是谁** 你是具有 ICSR 处理，全球安全监管和流程管理的经验的药物警专业人士，对驾驶质量，合规性和运营卓越性充满热情。你擅长将复杂的法规和商业要求转化为实际过程，程序，培训和系统解决方案，同时建立在安全，质量，业务和技术功能上强有力的伙伴关系。你是一个积极的问题解决者，拥有强大的组织和沟通技能，在动态环境中繁荣，致力于持续改善，检查准备以及支持患者安全。**需要技能** - 护理，药业，生命科学或相关学历
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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 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](https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.biogen.com%2Fresponsibility%2Fdiversity-inclusion.html&data=05%7C01%7Cdennis.mercier%40biogen.com%7C67adaf5a6edd4324716208db0dcd2182%7C7b7466bbfe1d47a0b9438ded565c8e54%7C0%7C0%7C638118946897044815%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=p2vFGx6ZWK7lyBEL4wuNIQJcKSVRZD90VuJxcOkjX04%3D&reserved=0) to learn more about our 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.