Senior Scientist, Drug Safety

About the role

The Senior Scientist, Drug Safety will support Clinical Safety and Risk Management activities for medical devices and product quality. Working under an Associate Principal or Principal Scientist, the role acts as a liaison across Research Laboratories, Device Development, Manufacturing, Quality, Compliance and the Risk Management Safety Team throughout the product lifecycle.

Key responsibilities

• Monitor, triage and assess safety assessment requests from the CSRM DPQ mailbox.
• Partner with the CSRM DPQ Risk Assessment Physician to produce Medical Assessment Memos or Health Hazard Evaluations.
• Author safety assessments for quality investigations related to GMP deviations, complaints, regulatory non‑conformances or other drug/device issues.
• Collaborate with requestors and functional teams to gather all relevant information for accurate assessments.
• Review adverse event quality investigation reports and maintain DPQ templates.
• Support device aggregate safety surveillance, risk management initiatives, and departmental standards, processes, and metrics.

Required profile

• Medical degree (MD) with at least 2 years of direct patient care experience.
• English proficiency at C1 level.
• Desirable experience in the pharmaceutical industry and a Master’s or specialization in Public Health or Epidemiology.
• Proficiency with the Microsoft Office Suite.

Required skills

• Adverse Event Reporting
• Clinical Risk Management
• Clinical Safety
• Data Analysis
• Data Integrity
• Device Development
• Drug Safety Surveillance
• Good Clinical Practice (GCP)
• Hazard Analysis
• Medical Writing
• Pharmacovigilance
• Product Portfolio Management
• Product Risk Management
• Quality Assurance Review
• Quality Management
• Regulatory Compliance
• Risk Management
• Safety Audits
• Safety Observations
• Safety Reporting
• Microsoft Office Suite