Global Product Safety Science Lead

🔥 20 hours ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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Sobi - Swedish Orphan Biovitrum AB (publ)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1991

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

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 for assigned products • Set strategies for safety signal detection methodology, signal tracking and oversight • Drive and document benefit-risk evaluations and implement risk-management strategies • Lead assessments and preparation, review and approval of PSURs, DSURs, RMPs and regulatory responses • Translate safety data insights into recommendations for product-level benefit-risk discussions and regulatory interactions • Lead clinical safety science interactions with partner companies and ensure safety-information sharing • Provide safety scientific input to the ISS Evaluation Committee • Assess product-quality escalation impacts on patients and lead Health Hazard Assessment statements when required • Represent Safety Science in the Medical Development Team and integrate safety into development and lifecycle decisions • Provide clinical safety input into study design, conduct, analysis and interpretation • Provide medical and pharmacovigilance expertise for clinical safety strategy, Target Product Profile, RSI, IB and CDS governance • Chair product-level Benefit Risk Teams and represent them at the Benefit Risk Council • Serve as primary decision-maker for product-level safety issues • Lead interactions with external partners and service providers • Support product-level regulatory interactions, inspections and audits • Mentor colleagues and support capability development • Use and develop safety systems, data visualization tools and AI-enabled analyses for signal detection, safety assessments and decision-making • Identify process, data and system improvement opportunities within Safety Science • Work independently with accountability for assigned products and escalate complex issues appropriately

🎯 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, including GVP and ICH E2E • Proficiency to analyse and synthesize medical and scientific safety data and contribute to scientific interpretation • Strong communication and stakeholder collaboration skills • Proficiency in Excel, database querying such as SQL, basic data visualization such as Power BI and Spotfire, and AI-related tools • Experience working with development programs and products with market approvals • Experience leading cross-functional global product safety management teams and delivering medical safety strategy • Experience across safety signal processes, aggregate report writing, safety risk communication and safety risk management • High-quality written and spoken English • Strong analytical skills • Effective oral, written and presentation communication skills • Ability to work effectively to fulfil ambitious goals • Sound and balanced judgment; ability to assess and handle risks; self-confidence, proactivity and decisiveness • Demonstrated ability to lead safety activities and scientific discussions • Strong team-leadership capabilities • Demonstrated relationship-building and collaboration skills internally and externally

🏖️ Benefits

• Employees can work remotely