Director, Safety Scientist, Pharmacovigilance
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，以确定新药目标并开发有效治疗治疗精神病症状。你会做什么？安全科学家将负责高质量的安全监测活动，包括医疗审查单个案例安全报告 (ICSR),综合报告协调生产，安全治理会议，安全信号检测和评估以及分配产品的安全风险管理活动。该个人将与计划安全领导和其他项目团队成员，药物警行动和 CRO 合作以确保符合全球规范的积极安全监测。责任：·管理安全监控和信号检测活动 （综合安全数据的期内审查，安全监督团队会议，轨道信号及相关文件）·代表分配产品的临床研究小组中的光伏；根据需要制定该项目的安全指导核实安全信号的信号评估报告 · 与光伏操作协作，以便对 ICSR 进行及时准确的医学审查，用于指定临床研究 · 制定和贡献整个产品生命周期的安全风险管理计划 · 开发和管理定期报告 (DSUR/PBRER) · 参与数据分析和监管提交和监管响应的安全部分编写 · 促进安全监督和风险管理 SOP,模板等的发展或更新。· 与临床研究团队合作在安全监测结果 （IB,RSI,协议，简报文件等）· 参加光伏审计和检查 · 在适当的情况下代表委员会和外部活动中的药物警功能。我们考虑这些行为，我们寻求在所有 MapLight 员工中。·你能与多个跨职业团队参与并有效地合作。·你具有强大的人际关系技能和理解关系是成功的关键。·你是一个领导者。团队喜欢与你一起工作，你为指导和支持他人职业生涯而自豪的人。·你是一名愿意起袖子完成的工作的团队玩家。
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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 Safety Scientist will be responsible for high quality safety surveillance activities including medical review of individual case safety reports (ICSRs), aggregate report production, safety governance meeting coordination, safety signal detection and assessment, and safety risk management activities for assigned products. This individual will collaborate with Program Safety Lead and other program team members, pharmacovigilance operations, and CROs to ensure proactive safety surveillance in compliance with global regulations.
Responsibilities:
- Manage safety surveillance and signal detection activities (period review of aggregate safety data, safety surveillance team meetings, track signals and related documentation)
- Represent PV at clinical study team for assigned product
- Develop signal assessment report under the oversight of Program safety lead for validated safety signal
- Collaborate with PV operations for timely and accurate medical review of ICSRs for assigned clinical study as needed
- Develop and contribute safety risk management plan across product lifecycle
- Develop and manage periodic reports (DSUR/PBRER)
- Contribute for data analysis and authoring of safety sections for regulatory submissions and regulatory responses
- Contribute for the development or updates of safety surveillance and risk management SOPs, templates etc.
- Collaborate with clinical study teams on safety surveillance deliverables (IB, RSI, Protocol, Briefing documents etc.)
- Participating in PV audit and inspections
- Represent Pharmacovigilance function in committees and activities both internally and externally when appropriate.
We consider these behaviors we seek in all MapLight employees.
- You can participate and work effectively with multiple cross-functional teams.
- You have strong interpersonal skills and understanding relationships are key to being successful.
- You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others.
- You’re a team player who is willing to roll up your sleeves and get the job done.
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 epidemiology (e.g. MPH)
- Minimum 10 years of pharmacovigilance experience within the biopharmaceutical industry with at least 3 years of direct clinical/patient care experience
- Preferred: Safety surveillance and risk management experience in neuroscience, psychiatry or neurodegenerative disease area
- Competence in conducting safety data reviews, 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
- 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.
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
$220,000—$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.