Global Product Safety Science Lead

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Conduct and oversee signal detection, assessment, validation, and escalation for designated products.

• Establish strategies for safety signal detection methodologies, signal tracking, and monitoring.

• Lead and document benefit-risk evaluations while implementing risk management strategies.

• Oversee the assessments, preparation, review, and approval of PSURs, DSURs, RMPs, and regulatory responses.

• Convert safety data insights into recommendations for product-level benefit-risk discussions and regulatory engagements.

• Direct clinical safety science interactions with partner organizations and ensure the sharing of safety information.

• Provide scientific safety input to the ISS Evaluation Committee.

• Evaluate the impact of product-quality escalations on patients and lead Health Hazard Assessment statements when necessary.

• Represent Safety Science within the Medical Development Team and incorporate safety considerations into development and lifecycle decisions.

• Offer clinical safety input into study design, execution, 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.

• Act as the primary decision-maker for product-level safety concerns.

• Lead interactions with external partners and service providers.

• Assist with product-level regulatory interactions, inspections, and audits.

• Mentor colleagues and promote capability development.

• Utilize and enhance safety systems, data visualization tools, and AI-enabled analyses for signal detection, safety assessments, and decision-making.

• Identify opportunities for process, data, and system improvements within Safety Science.

• Operate independently with accountability for assigned products and appropriately escalate complex issues.

⛳️ Requirements

• MD, PharmD, PhD, or Master’s degree in Life Sciences/Public Health.

• Substantial experience in pharmacovigilance and safety science within a pharmaceutical or regulatory setting.

• Comprehensive knowledge of global PV regulations, including GVP and ICH E2E.

• Ability to analyze and synthesize medical and scientific safety data and contribute to scientific interpretations.

• Excellent communication and stakeholder collaboration abilities.

• Proficiency in Excel, database querying such as SQL, basic data visualization tools like Power BI and Spotfire, and AI-related technologies.

• Experience with development programs and products that have received market approvals.

• Proven experience in leading cross-functional global product safety management teams and delivering medical safety strategies.

• Familiarity with safety signal processes, aggregate report writing, safety risk communication, and safety risk management.

• High-quality written and spoken English proficiency.

• Strong analytical capabilities.

• Effective oral, written, and presentation communication skills.

• Ability to work efficiently towards achieving ambitious goals.

• Sound and balanced judgment; capability to assess and manage risks; self-assuredness, proactivity, and decisiveness.

• Proven ability to lead safety activities and scientific discussions.

• Strong team leadership skills.

• Demonstrated ability to build relationships and collaborate both internally and externally.

🏝️ Benefits

• Employees have the option to work remotely.