POSITION LOCATION: Canada (Home-based)
POSITION TITLE: Clinical Safety Specialist
POSITION REPORTS TO: Manager, Regulatory Affairs
DEPARTMENT/UNIT NAME: Regulatory Affairs
Responsible for the day-to-day activities and supporting the delivery of global project safety and pharmacovigilance services. The Clinical Safety Specialist will do the following: (1) perform all aspects of safety case management, including: initial receipt, data entry, document management, triage, queries, review, close; (2) support peers, project teams and stakeholders in the development and/or the review of safety plans, product safety information, adverse event documentation and regulatory safety submissions; (3) support the development of safety components of patient consent forms and site and patient educational materials to ensure high quality, timely service delivery; and (4) ensure safety processes are maintained and delivered in accordance with corporate, industry, regulatory and trial conduct requirements and patient safety standards.
ROLE & RESPONSIBILITIES:
- Coordinate the day-to-day delivery of clinical trial safety services and processes, including compilation of regulatory filings/submissions/revisions for projects, third party vendors and clinical sites.
- Conduct and support quality and regulatory safety reviews and assist with the development of regulatory safety related tools and educational/training materials.
- Remain current on all aspects of clinical trial safety requirements and industry best practices, communicating changes to project leaders in a timely manner.
- Support the selection and management of safety vendors as required (e.g. technical experts, technology solutions).
- Provide regulatory and/or pharmacovigilance support to project team and stakeholders.
- Represent clinical safety at project meetings.
- Assist with project education and safety monitoring.
- Support regulatory and safety data reviews and audits to assure sponsor expectations are managed and met.
- Support resolution of clinical safety issues with government, regulatory agencies or external groups as required.
Safety Strategy Development
- Implement and maintain safety strategies, working with other experts (regulatory, quality assurance, medical monitoring) appropriately to meet compliance and patient safety requirements.
- Follow good clinical practices while striving to continually improve project related safety procedures.
Safety Case Management
- Independently manage individual case safety reports for reported adverse events.
- Interpret and evaluate individual case safety reports.
- Coordinate the processing of adverse events; including data entry and document management activities.
- Coordinate the completion of serious adverse event narrative summaries.
- Support the coding of adverse event data to the MedDRA dictionary and WHODRUG dictionary.
- Support the interpretation and evaluation aggregate safety data.
- Support the development of written safety data analyses.
- Participate in risk management activities.
- Regularly report to project stakeholder(s) on cumulative findings.
- Assure all annual safety reports are accurately completed in compliance with jurisdictional regulatory standards and guidelines, as well as project and corporate timelines.
Subject Matter Expert
- Regularly liaise with Project teams, Clinical Sites, Medical Experts and Sponsors to identify, resolve or facilitate the resolution of clinical trial safety issues as they arise throughout the project life cycle.
- Facilitate regular review of project medical/drug terminologies, consent forms, and SAE assessments to confirm safety related documents align with project specifications and that all stakeholders are promptly informed and/or trained on trial safety related findings and changes.
Applicants should have a minimum of an undergraduate degree in a health/life sciences field (advanced degrees preferred) and 3-5 years of relevant experience in Clinical/Drug Safety. In addition, the preferred candidate will have experience/knowledge of Drug Safety Systems and possess strong case management and communication skills.
*Accommodations for job applicants with disabilities are available upon request.