Sobi - Swedish Orphan Biovitrum AB (publ)
1001 - 5000 employees
Founded 1991
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
Sobi - Swedish Orphan Biovitrum AB (publ) is a global leader in providing innovative treatments for people with rare diseases. Specializing in therapeutic areas such as haematology and immunology, Sobi is committed to improving patient access to medicines for rare and debilitating conditions. With a strong R&D pipeline, the company is actively pursuing new therapies and collaborating globally to transform patient care in areas such as haemophilia and immune thrombocytopenia. Sobi also engages in extensive sustainability and humanitarian aid programs, demonstrating a firm commitment to patient-centric care and societal contributions.
Global Product Safety Science Lead
🔥 0 minutes ago
📊 Check your resume score for this job
Improve your chances of getting an interview by checking your resume score before you apply.
Sobi - Swedish Orphan Biovitrum AB (publ)
1001 - 5000 employees
Founded 1991
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
Sobi - Swedish Orphan Biovitrum AB (publ) is a global leader in providing innovative treatments for people with rare diseases. Specializing in therapeutic areas such as haematology and immunology, Sobi is committed to improving patient access to medicines for rare and debilitating conditions. With a strong R&D pipeline, the company is actively pursuing new therapies and collaborating globally to transform patient care in areas such as haemophilia and immune thrombocytopenia. Sobi also engages in extensive sustainability and humanitarian aid programs, demonstrating a firm commitment to patient-centric care and societal contributions.
📋 Description
• 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. • 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. • Chair product‑level Benefit Risk Teams (BRTs) and ensure effective operation per SOPs.
🎯 Requirements
• 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
Apply Now
