Product Lead

• 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

Product Lead jobs in Switzerland

Global Product Safety Science Lead