Global Product Safety Science Lead

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Sobi - Swedish Orphan Biovitrum AB (publ)

WebsiteLinkedInAll Job Openings

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 safety surveillance and benefit–risk activities for assigned products • Set the strategy for safety signal detection methodology • Drive, perform and document benefit-risk evaluations and ensure appropriate risk-management strategies are implemented • Lead and perform assessments for preparation, review and approval of key safety deliverables • Translate safety data insights into actionable recommendations • Lead clinical safety science interactions with partner companies • Act as the Safety Science representative in the Medical Development Team (MDT) • Provide clinical safety input into study design, conduct, analysis and interpretation • Chair product-level Benefit Risk Teams (BRTs) • Represent the BRT at Benefit Risk Council (BRC) • Mentor colleagues and support capability development within the product safety team

🎯 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 • Demonstrated expertise in the understanding, interpretation, and application of various country/regional pharmacovigilance requirements

🏖️ Benefits

• N/A