Assoc Medical Mgr PSS

Accountabilities: • Medical Safety Review: Conduct primary medical reviews of safety cases involving drugs, medical devices, and combination products, assessing seriousness, listedness and labeling, causality, adverse event coding, and case narratives.

• Case Documentation and Tracking: Maintain accurate and up-to-date case information, document feedback, and use designated trackers and workflow tools to support efficient case management.

• Quality and Productivity: Take ownership of assigned deliverables, ensuring compliance with established quality standards, service-level agreements (SLAs), key performance indicators (KPIs), and applicable regulatory requirements.

• Medical Guidance and Training: Provide medical guidance, training, and support to case processing teams to strengthen case assessment quality and consistency.

• Quality Control and Assurance: Perform secondary medical reviews and retrospective quality reviews as required, evaluating deliverable quality and identifying recurring errors, training needs, and opportunities for improvement.

• Regulatory Compliance: Apply relevant clinical research, pharmacovigilance, and medical safety requirements when reviewing and documenting cases.

• Continuous Improvement: Contribute to process enhancements and other assigned activities that support effective safety operations, quality management, and patient protection.

Requirements:

• Medical Qualification: Medical degree (MD or DO) required. Relevant equivalent experience may be considered in lieu of educational requirements, subject to the employer’s assessment.

• Pharmacovigilance Experience: At least 4 years of pharmacovigilance experience, including clinical trial and post-approval experience.

• Drug Safety Expertise: Strong knowledge of adverse event assessment, case processing, medical review, drug safety, and pharmacovigilance practices.

• Medical Knowledge: Working knowledge of medical sciences, diagnosis, therapeutics, drug treatments, and clinical procedures.

• Regulatory Knowledge: Understanding of regulatory requirements for clinical research and pharmacovigilance, including International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines.

• US Healthcare Knowledge: Comprehensive understanding of the US healthcare system.

• English Proficiency: Strong English communication skills across speaking, writing, and reading.

• Attention to Detail: Ability to assess complex medical information accurately, maintain thorough documentation, and uphold high standards of quality and compliance.

• Organization and Accountability: Ability to manage multiple deliverables, meet deadlines, and maintain expected productivity and quality standards in a fast-paced environment.

• Preferred Clinical Credentials: Completion of an accredited medical residency program or equivalent, with board eligibility or certification.

• Preferred Industry Background: At least 4 years of pharmaceutical industry experience, particularly in pharmacovigilance, post-approval safety, case processing, medical review, and/or clinical research.

• Preferred Clinical Practice: 1–2 years of clinical practice experience.

• Preferred Specialized Expertise: Substantial knowledge of global pharmacovigilance regulations, drug safety, and risk management.

Benefits:

• Competitive Salary: Annual pay range of CAD $100,000–$110,000.

• Remote Work: Full-time, home-based position within Canada.

• Professional Impact: Opportunity to apply medical expertise to patient safety and the evaluation of drug and medical product risks.

• Specialized Experience: Work across post-marketing safety activities and contribute to pharmacovigilance quality and compliance.

• Collaborative Environment: Partner with case processing professionals and support team development through medical guidance and training.

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