Global Product Safety Science Lead

The Global Product Safety Science Lead (GPSSL) at Sobi is a pivotal role within an international biopharmaceutical company. Sobi focuses on developing and providing innovative treatments for rare diseases in the fields of haematology, immunology, and specialty care. The company has its headquarters in Stockholm, Sweden, and additional premises in Basel, Switzerland. The GPSSL's main responsibilities include performing and leading safety surveillance and benefit-risk activities for assigned products. This involves signal detection, evaluation, validation, and escalation, as well as driving safety strategy implementation. The role requires active participation in the Medical Development Team (MDT) to ensure safety considerations are integrated into development and lifecycle decisions. The GPSSL also chairs benefit-risk discussions, prepares and reviews key safety deliverables, and translates safety data insights into actionable recommendations. Additionally, the role involves leading clinical safety science interactions with partner companies and providing safety scientific input to the ISS Evaluation Committee. To qualify for this role, candidates must have an MD, PharmD, PhD, or Master's in Life Sciences/Public Health. They need solid experience in pharmacovigilance and safety science within a pharmaceutical or regulatory environment. Proficiency in global PV regulations, such as GVP and ICH E2E, is essential. Strong analytical skills and the ability to synthesize medical and scientific safety data are also required. Proficiency in Excel, database querying, and basic data visualization tools, as well as AI-related tools, is necessary. Experience working with development programs and products with market approvals, as well as leading cross-functional global product safety management teams, is crucial. Nice-to-have skills include experience working with partner companies to develop and market products globally, and presenting medical safety information at Health Authority meetings. The role is based in Stockholm, Sweden, and offers a collaborative team environment with opportunities for continuous improvement and data-driven decision-making. The GPSSL works independently with accountability for assigned products, escalating complex or cross-product issues as appropriate. What the role asks for: - An 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). - Proficiency in Excel, database querying (e.g., SQL), and basic data visualization (e.g., Power BI, Spotfire). - Proficiency in AI-related tools. - Experience working with development programs and with products with market approvals. - Experience leading cross-functional global product safety management teams. - High quality written and spoken English.