Global Product Safety Science Lead

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). Translat