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Associate Medical Safety Director- Sponsor Dedicated (Home-Based)

IQVIA

IQVIA seeks an Associate Medical Safety Director to support lifecycle safety activities for assigned product portfolios. The role encompasses medical review of adverse events, signal detection, regulatory report preparation, and risk management oversight in a home-based setting.

Responsibilities

  • Conduct aggregate safety reviews and maintain oversight of product safety profiles across clinical and post-marketing data
  • Lead signal detection, analysis, and evaluation; contribute to safety analysis reports and presentations
  • Provide medical review and contribute to regulatory reports including IND annuals, EU periodic reports, and risk management plans
  • Review and clarify trial adverse events and post-marketing adverse drug reactions; serve as internal consultant to pharmacovigilance teams
  • Represent safety findings in internal and external stakeholder meetings; support safety governance activities

Requirements

  • Medical degree from accredited, internationally recognized institution
  • Three years clinical practice plus two years pharmaceutical industry experience or equivalent
  • Knowledge of clinical research regulations, GCP, and pharmaceutical development processes
  • Experience in signal detection, aggregate safety reports, and risk management
  • Ability to synthesize complex clinical data and communicate findings orally and in writing
  • Strong organizational skills with capacity to manage multiple priorities and work under pressure

Compensation: €53,000–€90,200 base

Pracovná ponuka zverejnená dňa Pred 3 dňami