Global Product Safety Science Lead

🔥 16 hours ago

🇨🇭 Switzerland – Remote

⏰ Full Time

🟠 Senior

✨ Product Lead

👻 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 activities for assigned products • Set the strategy for safety signal detection methodology, signal tracking and oversight of safety signals • Drive, perform and document benefit-risk evaluations and ensure appropriate risk-management strategies are implemented • Lead and perform assessments for key safety deliverables, including PSURs, DSURs, RMPs and regulatory responses • Translate safety data insights into actionable recommendations for product-level benefit-risk discussions and regulatory interactions • Lead clinical safety science interactions with partner companies and ensure sharing of safety information per the SDEA and collaborative functioning of the JSMT • Provide safety scientific input to the ISS Evaluation Committee as required • Work cross-functionally on product quality escalations and, when required, lead preparation of medical impact Health Hazard Assessment statements • Act as Safety Science representative in the Medical Development Team and integrate 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 • Provide medical and pharmacovigilance expertise for clinical safety strategy, Target Product Profile, and maintenance of the RSI, including IB and CDS governance • Chair product-level Benefit Risk Teams and represent the BRT at Benefit Risk Council • Serve as primary decision-maker for product-level safety issues, including signal validation and escalation • Lead interactions with external partners and service providers related to product safety deliverables • Support product-level regulatory interactions, inspections and audits • Mentor colleagues and support capability development within the product safety team • Use and develop safety systems, data visualization tools and AI-enabled analyses to support signal detection, safety assessments and decision-making • Identify opportunities for process, data and system improvements within Safety Science • Work independently with accountability for assigned products, escalating complex or cross-product issues as appropriate

🎯 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 • Desired: Experience presenting medical safety information at Health Authority meetings • Desired: Demonstrated expertise in the understanding, interpretation, and application of various country/regional pharmacovigilance requirements • High quality written and spoken English • Strong analytical skills • Effective communicator (oral, writing, presentations) at all levels of the business • Ability to work effectively to fulfil ambitious goals • Sound and balanced judgment skills; able to assess and handle risks; self-confident, proactive and decisive • Demonstrated ability to lead safety activities and scientific discussions • Strong team-leadership capabilities • Demonstrated relationship builder both internally and externally; a strong collaborator within PV function, leadership and the wider organisation

🏖️ Benefits

• Employees can work remotely