Global Product Safety Science Lead

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

📋 Description

• Execute and oversee safety surveillance and benefit–risk initiatives for designated products.

• Establish the strategy for safety signal detection methodologies.

• Drive, conduct, and document benefit-risk assessments, ensuring the implementation of appropriate risk-management strategies.

• Lead and perform evaluations for the preparation, review, and approval of critical safety deliverables.

• Convert safety data insights into actionable recommendations.

• Lead interactions in clinical safety science with partner organizations.

• Serve as the Safety Science representative within the Medical Development Team (MDT).

• Provide clinical safety insights into study design, execution, analysis, and interpretation.

• Chair product-level Benefit Risk Teams (BRTs).

• Represent the BRT at the Benefit Risk Council (BRC).

• Mentor peers and assist in capability development within the product safety team.

⛳️ Requirements

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

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

• In-depth knowledge of global pharmacovigilance regulations (e.g., GVP, ICH E2E), along with relevant processes and practices.

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

• Excellent communication and stakeholder collaboration skills.

• Proficiency in Excel, database querying (e.g., SQL), and basic data visualization tools (e.g., Power BI, Spotfire), along with AI-related tools.

• Experience in managing development programs and products with market approvals.

• Proven track record in leading cross-functional global product safety management teams.

• Demonstrated expertise in understanding, interpreting, and applying various country/regional pharmacovigilance requirements.

🏝️ Benefits

• N/A