Global Product Safety Science Lead

📋 Description

• Perform and lead signal detection, evaluation, validation and escalation activities for assigned
• Set the strategy for safety signal detection methodology, signal tracking and oversight of safety
• Drive, perform and document benefit-risk evaluations and ensure appropriate risk-management
• Lead and perform assessments for the preparation, review and approval of key safety deliverables
• Translate safety data insights into actionable recommendations for product-level benefit-risk
• Act as the Safety Science representative in the Medical Development Team (MDT) and ensure

🎯 Requirements

• MD, PharmD, PhD or Master's in Life Sciences/Public Health
• Solid experience in pharmacovigilance and safety science within a pharmaceutical or regulatory
• Strong knowledge of global PV regulations (e.g., GVP, ICH E2E), pharmacovigilance processes and
• Proficiency to analyse, synthesize medical & scientific safety data and contribute to
• Strong communication & stakeholder collaboration skills
• Proficiency in Excel, database querying (e.g., SQL), and basic data visualization (e.g., Power BI