Medical Safety Associate Specialist
3 weeks ago
Brunel is hiring a Medical Safety Associate Specialist for one of our pharmaceutical clients. This renewable contract position offers the opportunity to work fully remotely in Ontario or Quebec.
About the RoleThis role supports coordinators with case management activities, ensuring compliance with corporate and local requirements and timelines. The successful candidate will be responsible for data entry of individual case safety reports (ICSRs) to pharmacovigilance safety databases.
Key Responsibilities:
- Data Entry: Enter ICSRs into pharmacovigilance safety databases as per corporate and local requirements and timelines.
- Expedited Reporting: Submit ICSRs for marketed products and medical devices subject to expedited reporting according to Canadian regulations within prescribed timelines.
- Follow-up Requests: Monitor and support the preparation of written follow-up requests to meet local/global and corporate requirements.
- Vendor Management: Perform reconciliations of company third-party vendors' programs, licensed partners, and inter-departmental teams as per corporate requirements.
- Metric Generation: Provide support for the compliance monitoring of Individual Case Safety Reports (ICSRs) and generating metrics on case handling.
- Vendor Training: Manage external vendor training records, including launching annual refresher training.
- CANADA Vigilance: Process Canada Vigilance queries and Access to Information requests/results.
- Report Analysis: Support analysis of reports in PV databases.
- Stakeholder Engagement: Respond to queries and requests from internal and external stakeholders.
- Project Support: Collaborate with Project Leaders in compiling information for the LPSMF on a regular basis.
- SOP Development: Participate in developing and maintaining the local Pharmacovigilance standard operating procedures (SOPs), working instructions, and job aids.
We are seeking an experienced professional with a strong working knowledge of FDA, Health Canada, and/or EMA regulations/guidance/guidelines with respect to clinical safety/pharmacovigilance.
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