Associate II Patient Safety Solutions (PSS)
New
F
FortreaPharmacovigilance
Remote based in CanadaFull-TimeMiddle
Salary67,000 - 82,000 CAD per year
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Job Details
- Languages
- English
- Experience
- Minimum of two years of pharmacovigilance (PV) work experience
- Required Skills
- Microsoft Office
Requirements
- Associate degree with 2 years of safety experience, or Bachelor's/Master's/PharmD with 1 year of safety experience.
- Minimum of 2 years of pharmacovigilance work experience in Canada or the US.
- Proven expertise in processing U.S. post-approval cases.
- Proficiency with the Argus safety database.
- Advanced command of English (speaking, writing, and reading).
- Strong knowledge of ICH guidelines and global regulatory reporting requirements.
- Proficiency with Microsoft Office Suite and Windows environment.
- Strong attention to detail with a high degree of accuracy.
- Ability to work independently with minimal supervision.
Responsibilities
- Manage receipt and processing of adverse event reports from clinical trials or spontaneous sources.
- Perform case triage to prioritize daily workflow and conduct medical adjudication using WHO-UMC.
- Enter safety data into adverse event databases and tracking systems.
- Write patient narratives and code events using MedDRA.
- Ensure timely expedited reporting to worldwide regulatory agencies.
- Support root cause analysis, CAPA plan development, and preparation for audits and inspections.
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