Pharmacovigilance Scientist

The Pharmacovigilance Scientist plays a critical role in the collection, evaluation, and management of drug safety data throughout clinical development. This role supports the monitoring and assessment of adverse events, safety signal detection, and risk management activities to safeguard patient safety and ensure regulatory compliance.

The Pharmacovigilance Scientist collaborates with cross-functional teams to maintain the integrity of safety data and contributes to the preparation of safety-related documentation, presentations, and aggregate reports. They work closely with the Senior Medical Director, Pharmacovigilance and Safety, to execute pharmacovigilance strategies.

Key Responsibilities:

• Safety Data Collection and Review:
  • Collects, reviews, and analyzes adverse event reports from clinical trials to identify potential safety signals
  • Supports quality control review of individual case safety reports (ICSRs)
  • Assists in ongoing safety monitoring activities, including data reconciliation and quality checks to ensure accuracy of safety data
  • Supports safety data management activities, including case processing, follow-up, and coding of adverse events
• Risk Assessment and Signal Detection:
  • Assesses clinical safety data to identify, evaluate, and document adverse events and emerging safety concerns
  • Contributes to risk-benefit analyses and supports the development of risk mitigation strategies
• Pharmacovigilance Documentation:
  • Supports the preparation and review of pharmacovigilance documents such as Development Safety Update Reports (DSURs), development Risk Management Plans (dRMPs), and relevant sections of clinical trial protocols, Investigational Brochures (IBs), and regulatory submissions
  • Proficient with safety surveillance systems and tools (e.g., Argus, MedDRA, Veeva Vault)
• Scientific Expertise:
  • Maintains current knowledge of relevant therapeutic areas, pharmacology, and drug safety regulations
  • Conducts literature reviews and safety signal assessments to inform safety evaluations
• Cross-Functional Collaboration:
  • Works closely with clinical operations, regulatory affairs, medical affairs, data management, bioinformatics, and project management teams to ensure comprehensive safety oversight
  • Supports compliance with global pharmacovigilance regulations and company safety policies
  • Supports the communication and oversight of pharmacovigilance and contract research organization vendors
  • Supports the project management of safety activities such as aggregate reports, safety team meetings, signal evaluations, etc.