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.