Global Product Safety Science Lead

Added
11 hours ago
Type
Full time
Salary
Salary not provided

Related skills

sql power bi pharmacovigilance gvp ich_e2e

📋 Description

  • Lead signal detection, evaluation, validation and escalation for assigned products.
  • Set strategy for safety signal detection and oversight of signals.
  • Drive benefit‑risk evaluations and risk-management strategies.
  • Lead PSURs, DSURs, RMPs and regulatory responses.
  • Translate safety data into actionable product benefit–risk recommendations.
  • Represent Safety Science in MDT and ensure safety integration in development.

🎯 Requirements

  • MD, PharmD, PhD or Master’s in Life Sciences/Public Health
  • Solid experience in pharmacovigilance and safety science within a pharmaceutical or regulatory environment
  • Strong knowledge of global PV regulations (GVP, ICH E2E) and pharmacovigilance processes
  • Proficiency to analyse, synthesize medical & scientific safety data and contribute to interpretation
  • High quality written and spoken English
  • Excel, SQL, and basic data visualization (Power BI, Spotfire), AI tools
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