Assoc Medical Mgr PSS

This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for an Associate Medical Manager – Patient Safety Solutions (PSS) based in Canada. We are seeking a medically qualified professional with strong pharmacovigilance expertise to support patient safety and the evaluation of adverse events associated with pharmaceutical products, medical devices, and combination products. In this full-time, fully remote role, you will conduct medical reviews of safety cases, assess potential risks, and ensure that case documentation meets regulatory and quality standards. You will contribute to post-marketing drug safety activities while applying your knowledge of clinical research, medical science, and global pharmacovigilance practices. Working closely with case processing teams, you will provide medical guidance, support quality assurance, and identify opportunities for continuous improvement. This position offers the opportunity to apply your clinical expertise in a collaborative, fast-paced environment focused on patient safety and regulatory compliance. The role is suited to a physician with substantial pharmacovigilance experience and a strong commitment to accuracy, quality, and effective teamwork. 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.