Senior Scientist – Drug Safety

About the role

Under the direction of an Associate Principal Scientist, the Senior Scientist – Drug Safety will support Clinical Safety and Risk Management activities for medical devices and drug products across the product lifecycle. The role acts as a liaison between research laboratories, device development, manufacturing, quality, compliance and the Risk Management Safety Team.

Key responsibilities

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

Required profile

• Medical degree (MD) with English proficiency at C1 level.
• Minimum two years of clinical experience providing direct patient care as a physician.
• Desirable experience in the pharmaceutical industry and a Master’s degree 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 Risk Management
• Quality Assurance Review
• Quality Management
• Regulatory Compliance
• Risk Management
• Safety Audits
• Safety Reporting