Lead signal detection, evaluation, validation, and escalation.
Define strategy for safety signal detection and tracking.
Lead benefit-risk evaluations and risk-management strategies.
Prepare and review PSURs, DSURs, RMPs, and regulatory responses.
Translate safety data into actionable recommendations for safety discussions.
Act as Safety Science representative in MDT; ensure safety in development decisions.

🎯 Requirements

MD, PharmD, PhD or Master's in Life Sciences/Public Health.
Solid experience in pharmacovigilance and safety science.
Strong knowledge of global PV regulations (GVP, ICH E2E).
Proficiency to analyze and interpret medical safety data.
Strong communication and stakeholder collaboration skills.
Excel, SQL, and basic data visualization (Power BI/Spotfire), AI tools.

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