全球产品安全科学负责人
Global Product Safety Science Lead
Sobi 是一家国际生物制药公司，致力于为血液学、免疫学和专科护理领域患有罕见疾病的患者提供创新治疗方案。Sobi 总部位于瑞典斯德哥尔摩，也在瑞士巴塞尔设有办公地点。有关 Sobi 的更多信息，请访问 www.sobi.com。
全球产品安全科学负责人（GPSSL）负责对一个或多个指定产品在整个产品生命周期内进行安全监测和获益-风险活动的执行与领导。
该职位结合了科学领导力和实际操作，并代表产品层面的主要安全负责人。
GPSSL 与安全科学团队的其他同事合作，推动安全策略的实施，主持获益-风险讨论，并确保跨职能产品团队中的高质量安全交付成果，包括积极参与医学开发团队（MDT），确保安全考虑充分融入开发和生命周期决策中，符合 GVP、GCP 和全球监管要求。
GPSSL 与 Sobi 全球药物警戒团队的其他成员以及其他内部职能或外部机构协作，以确保主动的安全管理、高质量的监管安全交付成果以及产品生命周期中临床安全信息的有效沟通。
产品层面的安全责任
· 对指定产品执行并领导信号检测、评估、验证和升级活动。
· 为指定产品的安全信号检测方法、信号跟踪及安全信号监督制定策略。
· 推动、执行并记录获益-风险评估，确保适当的风险管理策略得以实施。
· 领导并执行关键安全交付成果（如 PSUR、DSUR、RMP、监管回应）的准备、审查和批准评估。
· 将安全数据洞察转化为产品层面的获益-风险讨论和监管互动的可操作建议。
· 与指定产品的合作公司进行临床安全科学互动（如适用），确保按照 SDEA 分享安全信息，并建立和协同运作 JSMT。
· 根据需要向 ISS 评估委员会提供安全科学方面的输入。
· 在产品质量问题升级的情况下，跨职能协作
查看英文原文
Sobi is an international biopharmaceutical company, dedicated to providing access to innovative treatments that transform life for people with rare diseases in the areas of haematology, immunology and specialty care. With our head office in Stockholm, Sweden, Sobi also has premises in Basel, Switzerland. You can find more information about Sobi at www.sobi.com.
The Global Product Safety Science Lead (GPSSL) is responsible for performing and leading safety surveillance and benefit–risk activities for one or more assigned products across the product lifecycle.
This role combines scientific leadership and hands‑on execution and represents the primary product‑level safety owner.
The GPSSL drives safety strategy implementation in collaboration with other colleagues within Safety Science, chairs benefit–risk discussions and ensures high‑quality safety deliverables within cross‑functional product teams, including active participation in the Medical Development Team (MDT), ensuring that safety considerations are fully integrated into development and lifecycle decisions, in compliance with GVP, GCP and global regulatory requirements.
The GPSSL works collaboratively with other members of the Sobi Global Pharmacovigilance team, and other internal functions across Sobi or externally to ensure proactive safety management, high‑quality regulatory safety deliverables and effective communication of clinical safety throughout the product lifecycle.
Product-level safety ownership
· Perform and lead signal detection, evaluation, validation and escalation activities for assigned product(s).
· Set the strategy for safety signal detection methodology, signal tracking and oversight of safety signals for assigned products.
· Drive, perform and document benefit‑risk evaluations and ensure appropriate risk‑management strategies are implemented.
· Lead and perform assessments for the preparation, review and approval of key safety deliverables (e.g. PSURs, DSURs, RMPs, regulatory responses).
· Translate safety data insights into actionable recommendations for product‑level benefit–risk discussions and regulatory interactions.
· Lead the clinical safety science interactions with partner companies for the assigned products (if applicable) ensuring sharing of safety information per the SDEA and the set up and collaborative functioning of the JSMT.
· Provide safety scientific input to ISS Evaluation Committee as required.
· In case of product quality escalations, work cross functionally to understand impacts on patients, and (if required) lead the preparation of a medical impact Health Hazard Assessment statement.
Cross-functional execution (MDT)
· Act as the Safety Science representative in the Medical Development Team (MDT) and ensure integration of safety into product development and lifecycle decisions.
· Provide clinical safety input into study design, conduct, analysis and interpretation, including study‑level Safety Lead responsibilities where applicable.
· Provide medical and pharmacovigilance expertise e.g. for the clinical safety strategy of the product clinical development program, the development of the Target Product Profile (TPP), the development and maintenance of the RSI, including IB and CDS
Governance and decision-making
· Chair product‑level Benefit Risk Teams (BRTs) and ensure effective operation per SOPs.
· Represent the BRT at Benefit Risk Council (BRC).
· Serve as the primary decision-maker for product-level safety issues, including signal validation and escalation.
Collaboration and delivery
· Lead interactions with external partners and service providers related to assigned product safety deliverables.
· Support regulatory interactions, inspections and audits at product level.
People and capability development
· Mentor colleagues and support capability development within the product safety team.
Continuous improvement & data-driven decision making
· Actively use and continuously develop proficiency in safety systems, data visualization tools, and AI‑enabled analyses (e.g. Veeva Vault(s), analytics dashboards) to support robust and efficient signal detection, safety assessments, and decision‑making for assigned products.
· Identify opportunities for process, data and system improvements within Safety Science.
Level of autonomy: works independently with accountability for assigned products, escalating complex or cross‑product issues as appropriate.
Education/Learning Experience/Work Experience
Required:
· MD, PharmD, PhD or Master’s in Life Sciences/Public Health
· Solid experience in pharmacovigilance and safety science within a pharmaceutical or regulatory environment
· Strong knowledge of global PV regulations (e.g., GVP, ICH E2E), pharmacovigilance processes and practices
· Proficiency to analyse, synthesize medical & scientific safety data and contribute to scientific interpretation
· Strong communication & stakeholder collaboration skills
· Proficiency in Excel, database querying (e.g., SQL), and basic data visualization (e.g., Power BI, Spotfire), AI-related tools
· Experience working with development programs and with products with market approvals
· Experience leading cross functional global product safety management teams, successfully delivering medical safety strategy, with experience across safety signal process, aggregate report writing, safety risk communication and safety risk management
Desired:
· Experience working with partner companies to successfully develop and market products across global markets
· Experience presenting medical safety information at Health Authority meetings
· Demonstrated expertise in the understanding, interpretation, and application of various country/regional pharmacovigilance requirements
Skills/Knowledge/Languages
Required:
· High quality written and spoken English
· Strong analytical skills
· Effective communicator (oral, writing, presentations) at all levels of the business
· Ability to work effectively to fulfil ambitious goals
· Sound and balanced judgment skills; able to assess and handle risks; self-confident, proactive and decisive
· Demonstrated ability to lead safety activities and scientific discussions
· Strong team-leadership capabilities. Demonstrated relationship builder both internally and externally; a strong collaborator within PV function, leadership and the wider organisation