Director, Pharmacovigilance Operations
我们是谁：MapLight Therapeutics 是一家专注于中枢神经系统疾病的药物发现的临床阶段生物技术公司。我们结合了包括光基因学，实体生理学和空间转录学在内的尖端技术，以确定新型药物目标并开发有效治疗治疗精神病症状。你将做什么：医疗监督 (PV) 运营总监将通过合作伙伴和合同研究组织领导安全数据库和外包 PV 活动的战略，规划，执行和维护。报告给药物监督部副总裁，该人将负责监督从临床试验中收集，评估和报告安全数据，塑造公司的安全治理框架并支持与光伏运营相关的战略决策。责任：·制定光伏运行战略并支持光伏功能战略和愿景的实施；·为全球药物监测行动提供战略领导力，包括案例管理，供应商监督和综合报告。·管理 MPLT 安全系统 （安全数据库和流程）的实施，以符合法规的 ICSR 案件处理。·监督光伏供应商和合同管理 （例如第三方 CRO,合作伙伴）·监督与安全相关的联盟管理 (SDEA) ·在临床运营 （如光伏邮箱）协作中管理临床供应商之间的信息和数据流程 ·监督 ICSR 案件处理和报告质量和遵守性 (KPI) ·制定，贡献，审查和更新 ICSAR 案例处理 SOP,表格，SMP 等 ·与安全监控和跨职能团队联系以支持及时传播安全产品 ·与质量功能合作并领导 PV 对审计和检查的贡献。· PV 功能产品项目管理 · PV 函数贡献对 TMF 的监督 · PV 供应商的 PV 预算和资源管理 · PV 运营经理及导师合作人员资格：·医疗保健专业学位 （例如 RN,BSN, PharmD）或生物医学科学，制药学或相关生命科学高级学位。·优先级：研究生在企业管理或项目管理方面的培训 (MBA,PMP) ·最低8年在生物制药行业内执照药物工作经验
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Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.
What You’ll Do:
The Director, Pharmacovigilance (PV) Operations will lead the strategy, planning, execution, and maintenance of safety databases and outsourced PV activities through partners and contract research organizations. Reporting to the Vice President, Pharmacovigilance, this person will oversee the collection, evaluation, and reporting of safety data from clinical trials, shaping the company’s safety governance framework and supporting strategic decisions related to PV operations across programs.
Responsibilities:
- Develop strategy for PV operations and support PV Head in the implementation of strategy and vision for PV function
- Provide strategic leadership for global pharmacovigilance operations, including case management, vendor oversight, and aggregate reporting.
- Manage the implementation of MPLT safety system (safety database and process) for regulatory compliant ICSR case processing
- Oversight of PV vendor and contract management (e.g. third party CRO, partners)
- Oversight of alliance management related to safety (SDEAs)
- Manage flow of information and data between clinical and PV vendor in collaboration with Clinical operation (e.g. PV mailbox)
- Oversight of quality and compliance for ICSR case processing and reporting (KPI)
- Develop, contribute, review and maintain up to date ICSR case processing SOPs, forms, SMPs etc.
- Liaise with safety surveillance and cross-functional teams to support for timely dissemination of safety deliverables
- Collaborate with Quality function and lead PV contributions for audit and inspections
- Project management for PV functional deliverables
- Oversight of PV functional contributions to TMFs
- Manage PV budget and resources for PV vendor
- Coach and mentor PV operation associates
Qualifications:
- Health care professional degree (e.g. RN, BSN, PharmD) or advanced degree (Masters/PhD) in biomedical sciences, pharmaceutical sciences, or related life science.
- Preferred: Post-graduate training in business management or project management (MBA, PMP)
- Minimum 8 years of pharmacovigilance experience within the biopharmaceutical industry with at least 3 years in leading PV operations.
- Preferred: Experience in neuroscience, psychiatry or neurodegenerative disease area
- Competence in conducting safety data reviews, vendor management, preparation of aggregate reports, signal detection and risk management plans for investigational and/or post marketed products.
- Experience with MedDRA and drug coding reviews.
- Demonstrated expertise in global PV regulations, GVP and ICH guidelines, safety systems, and drug development processes.
- Experience in PV processes for individual case handling, signal management, aggregate data review, aggregate reports, and audits/inspections.
- Demonstrated PV project management skills in a fast-paced organization
- Exceptional communication and cross-functional collaboration skills.
- Strategic thinker with the ability to translate complex safety data into actionable insights for regulatory and clinical decision-making.
- Able to work within a growing organization and to help the organization evolve over time.
- Able to engage in an open, constructive and continuous dialogue with the Company’s stakeholders based on equality and mutual respect.
- Highly motivated, self-driven and dependable.
- Committed to MapLight's Core Beliefs and Values.
Travel: Ability to travel as needed (up to 10%) for corporate and departmental meetings.
MapLight is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave.
Salary Range
$205,000—$240,000 USD
EEOC Statement: MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.