Clinical Safety Data Associate

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Safety Data Associate based in Canada.** This role provides the opportunity to support clinical research programs by ensuring the accuracy, consistency, and quality of critical safety data. You will contribute to the review, coding, and management of clinical trial safety information across global studies. The position combines medical knowledge, data management expertise, and collaboration with multidisciplinary research teams. You will play an important role in identifying data issues, improving data quality, and supporting regulatory-compliant clinical development processes. The environment values precision, scientific excellence, teamwork, and continuous improvement within a growing research organization. This is an opportunity for professionals passionate about healthcare data and clinical trials to make a meaningful impact on patient safety and research outcomes. ### Accountabilities: The role is responsible for reviewing, managing, and supporting clinical safety data processes to ensure accurate, compliant, and high-quality information throughout clinical trials. - Develop and maintain safety data review plans, including standardized review checklists covering laboratory data, adverse events (AEs), serious adverse events (SAEs), medical events of special interest, medications, disease history, and study termination information. - Perform safety data reviews according to established plans and identify, document, and follow up on discrepancies until resolution. - Collaborate with Project Managers, Clinical Data Managers, and other stakeholders to maintain high-quality clinical trial data. - Provide medical guidance and support for SAE reconciliation activities when required. - Perform medical coding of adverse events, medical histories, and concomitant diseases using MedDRA terminology. - Perform medication coding using WHODrug dictionaries and ensure accurate, timely coding of clinical data. - Support clinical trial protocol reviews and evaluate Case Report Forms (CRFs/eCRFs) to improve data collection consistency and accuracy. - Provide input and review laboratory edit specifications, ensuring completeness, accuracy, and alignment across studies. - Review laboratory normal ranges and units from central and local laboratories, resolving inconsistencies with relevant teams. - Assist Clinical Data Managers with laboratory data management and resolution of related data issues. - Support coding dictionary version control and ensure compliance with study-specific requirements. - Contribute to Clinical Data Management initiatives and provide medical and coding support for programming and biostatistics activities as needed. ## Requirements: The ideal candidate has experience in clinical research, safety data management, and medical coding, with strong attention to detail and the ability to collaborate effectively across teams. - Bachelor’s, Master’s, or doctoral-level education in a health-related discipline such as Nursing, Medicine, Pharmacology, Pharmacy, Biomedical Sciences, or a related field. - 2–3 years of experience in clinical trial data management, including medical coding and laboratory data management. - Strong understanding of clinical trial safety data processes, coding practices, and data review methodologies. - Experience working with medical coding dictionaries such as MedDRA and WHODrug. - Ability to manage medical information accurately and maintain high-quality documentation. - Strong organizational skills with the ability to manage multiple priorities and projects independently. - Excellent written and verbal communication skills, with the ability to collaborate with professionals across clinical, medical, and administrative functions. - Strong analytical mindset and attention to detail when reviewing complex clinical data. ## Benefits: The role offers a comprehensive…