Kelly Science, Engineering, Technology & Telecom ยท 4 hours ago
Senior Pharmacovigilance Specialist
United States
Full-time
Remote
Senior Level
$50/hr - $50/hrKelly Science is seeking a Senior Pharmacovigilance Specialist for a growing company located in Boston, MA. The role involves managing adverse event records, supporting regulatory inspections, and ensuring compliance with safety regulations.
Staffing & Recruiting
Hiring Manager
Paula Picard
Responsibilities
Manage day-to-day case processing of adverse event records, ensuring accurate and timely documentation
Support regulatory inspections and audits related to pharmacovigilance activities
Evaluate safety data and proactively identify potential safety signals
Conduct medical evaluation of adverse event reports to assess severity and clinical relevance
Prepare, analyze, and submit expedited and periodic adverse event reports to the FDA
Perform reconciliation of adverse event data with Medical Information, Product Quality, and License Partners
Ensure compliance with local and international regulations, guidelines, and applicable directives regarding adverse event handling
Collaborate with internal teams, commercial partners, and PV vendors to exchange and update safety information, including performing reconciliations
Maintain thorough documentation to support regulatory requirements and audit readiness
Contribute to continuous process improvement initiatives within the pharmacovigilance function
Qualification
Required
Bachelor's degree in Nursing or a related scientific field
Previous experience with safety systems including Argus and Aris-G and clinical experience with AE/SAE assessments
Previous Postmarketing Adverse Drug Experience is required along with experience working with service providers
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
Founded in 1946
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
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