Prevail InfoWorks ยท 2 days ago
Pharmacovigilance Analyst
United States
Full-time
Remote
Mid, Senior Level
5+ years exp
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Responsibilities
Management of safety cases and reports from all sources, including case intake/triage, data entry, quality review, medical review, and follow up activities
Electronic documentation and filing of safety information according to SOPs and safety management processes
MedDRA coding of data in the safety database
Preparation of case narratives
Reconciliation of the clinical and safety databases
Provide support for regulatory submission preparation and review
Coordinate safety project setup, including safety database build
Author sponsor/project specific safety management plans
Conduct and assess literature searches
Participate in sponsor/investigator meetings as required
Maintain a working knowledge of the safety database
Maintain working knowledge of global regulatory rules and regulations, including monitoring for new or changing regulation
Perform other duties as assigned
Qualification
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Required
Pharmacovigilance knowledge and experience including safety case processing for clinical trials (drugs, biologics, vaccines, and medical devices). Nursing experience is a plus.
Proficient in MS Office and Adobe Acrobat
Good Understanding of MedDRA & WHODrug Global dictionaries
Must display analytical and clinical skills
Requires narrative writing skills
Degree in Nursing, Life Science, or other health-related field, or equivalent qualification/work experience
Company
Prevail InfoWorks
Prevail InfoWorks is a system integration and analytics software company.
51-200 employees
H1B Sponsorship
Prevail InfoWorks has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Growth StageLeadership Team
Jack Houriet
Chief Executive Officer
Recent News
Company data provided by crunchbase
