Job Title: Drug Safety Physician
Location: Remote, Canada
Job Type: Regular Full-time
Division: Precision for Medicine
Business Unit: Clinical Solutions
Requisition Number: 5824
Position Summary
The Drug Safety Physician is responsible for leading the pharmacovigilance function, including medical review and oversight of safety event processing. This role provides clinical support in drug safety data management, interpretation, and risk management activities. The position ensures timely and accurate safety reporting aligned with FDA, EMA, ICH guidelines, applicable regulations, GCP, and SOPs.
Key Responsibilities
Manage all aspects of Drug Safety and Pharmacovigilance including safety data review, signal detection, risk communication, and risk mitigation.
Provide medical and drug safety expertise to support decision-making based on risk-benefit assessments, clinical trial data, and individual case reports of Serious Adverse Events (SAEs).
Collaborate with CRO Safety Physicians, Medical Directors, Clinical Scientists, and other functions on safety monitoring, assessment, and reporting (both case and aggregate levels).
Contribute to safety-related sections in study protocols, reports, Investigator Brochures (IBs), Informed Consent Forms (ICFs), and regulatory responses.
Act as accountable point of contact for setting up and conducting Data Safety Monitoring Boards (DSMBs) and safety review meetings.
Participate in safety cohort reviews for ongoing Phase 1 dose escalation studies.
Oversee event coding review and reconciliation between clinical and safety databases for coding consistency.
Manage Drug Safety systems to ensure regulatory compliance and optimize safety monitoring, signal detection, and reporting.
Ensure effective SOPs and governance for safety vendors.
Recommend and plan the future development of Drug Safety and Pharmacovigilance functions to support regulatory filings and commercialization, including acquiring QPPV support and contributing to Risk Management Plans and the Pharmacovigilance System Master File (PSMF).
Maintain audit and inspection readiness of the Drug Safety function at all times.
Education and Experience Requirements
Required:
Medical Degree (MD).
Minimum 7 years’ experience in drug safety in pharma/biotech.
Clinical trial experience, with at least 3 years in early clinical development oncology drug safety.
Experience authoring, reviewing, and providing input on drug safety regulatory reports.
Successful participation in regulatory agency interactions or inspections.
Strong knowledge of FDA, EU, ICH, and other global safety reporting and risk management requirements.
Medical expertise and familiarity with hematology/oncology clinical trials and safety monitoring.
Proficient in Microsoft Office, safety databases, and ARGUS case processing.
Demonstrated ability to work under urgency and respond rapidly to emerging safety information.
Excellent oral and written communication skills.
Ability to collaborate effectively with internal teams and external vendors.
Self-motivated, conscientious, and enthusiastic about advancing therapies for human diseases.
Supervisory experience.
Willingness to travel less than 20%.
Other Required Competencies
Challenge existing practices to improve efficiency and effectiveness.
Adapt effectively to varying situations.
Meet quality and performance standards consistently.
Strong influencing and interpersonal skills.
Demonstrate ownership, initiative, and accountability.
Work effectively in a team and promote collaboration.
Ability to multi-task in a fast-paced environment.
Competencies and Behavioral Skills
Deliver on commitments with a strong service mindset.
Communicate clearly and effectively on safety issues with all stakeholders.
Ensure consistent safety assessments.
Serve as Drug Safety expert in cross-functional teams.
Monitor regulatory compliance for safety reporting throughout clinical trials.
Lead or contribute to process development and improvements supporting Drug Safety.
About Precision Medicine Group
Precision medicine is transforming cancer treatment by targeting tumors at a molecular level using biomarkers linked to specific mutations and therapies. We combine deep scientific knowledge with advanced technology and specialized expertise to design and execute targeted, adaptive clinical trials, providing robust insights that optimize oncology development pathways.
Important Notices
Beware of fraudulent employment offers posing as Precision Medicine Group. Legitimate offers come only through formal communication with recruiting teams and hiring managers after interviews.
For suspected recruitment fraud, report to the FTC at https://www.ftc.gov.
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