Overview
As GPSSL you lead and perform safety surveillance across the product lifecycle, acting as the primary safety owner. You shape safety strategy, drive benefit–risk assessments, and ensure high-quality regulatory deliverables in collaboration with Safety Science and cross-functional teams. You integrate safety considerations into development and lifecycle decisions within GVP/GCP guidelines. You will work with internal and external partners to manage proactive safety and clear communication of clinical safety throughout the product lifecycle. This role combines scientific leadership with hands-on execution and offers a meaningful opportunity to influence patient safety at scale.
Verantwortungsbereiche
- Lead product-level safety ownership and perform signal detection, evaluation, validation, and escalation for assigned products
- Set strategy for safety signal detection, signal tracking, and oversight of safety signals
- Drive and document benefit–risk evaluations and implement risk-management strategies
- Lead preparation, review, and approval of key safety deliverables (PSURs, DSURs, RMPs, regulatory responses)
- Translate safety insights into actionable recommendations for product-level benefit–risk discussions and regulatory interactions
- Lead clinical safety science interactions with partner companies (e.g., JSMT setup) ensuring safety information sharing per SDEA
- Provide safety input to ISS Evaluation Committee as required
- In case of product quality escalations, lead cross-functional medical impact assessments
- Act as Safety Science representative in MDT and integrate safety into development/lifecycle decisions
- Provide clinical safety input into study design, conduct, analysis, and interpretation; lead Safety Lead responsibilities when applicable
- Chair product-level Benefit Risk Teams (BRTs) and represent the BRT at the Benefit Risk Council (BRC)
- Lead external collaborations for product safety deliverables and support regulatory inspections and audits at product level
- Mentor colleagues and support capability development within the product safety team
- Continuously improve safety systems, data visualization tools, and AI-enabled analyses to support signal detection and decision-making
- Identify opportunities for process, data, and system improvements within Safety Science
- Work autonomously with accountability for assigned products, escalating complex issues as needed
Zentrale Anforderungen
- MD, PharmD, PhD or Master’s in Life Sciences/Public Health
- Solid experience in pharmacovigilance and safety science in pharma or regulatory settings
- Strong knowledge of global PV regulations (GVP, ICH E2E) and pharmacovigilance practices
- Ability to analyze and synthesize medical safety data and contribute to scientific interpretation
- Strong communication and stakeholder collaboration skills
- Proficiency in Excel, SQL, and basic data visualization (Power BI, Spotfire); familiarity with AI-related tools
- Experience with development programs and products with market approvals
- Experience leading cross-functional global product safety teams and delivering medical safety strategy across safety signal processes, aggregate reports, risk communication and risk management
- Strong communication and presentation skills
- Leadership and team-development capability
- Collaborative mindset and relationship-building
- Veeva Vault(s)
- Power BI
- Spotfire
Global Product Safety Science Lead in Basel Arbeitgeber: Swedish Orphan Biovitrum
Als Arbeitgeber bieten wir Ihnen die Möglichkeit, in einem dynamischen und internationalen Umfeld zu arbeiten, das sich auf den Zugang zu spezialisierten Gesundheitsprodukten konzentriert. Unsere Unternehmenskultur fördert Zusammenarbeit und Innovation, während wir Ihnen zahlreiche Möglichkeiten zur beruflichen Weiterentwicklung und zum Networking mit verschiedenen Stakeholdern bieten. Darüber hinaus profitieren Sie von flexiblen Arbeitsmodellen und einer positiven Work-Life-Balance, die es Ihnen ermöglichen, Ihre Karriere und Ihr persönliches Leben in Einklang zu bringen.
