Product Lead

• 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

Product Lead jobs in United Kingdom

Global Product Safety Science Lead