Job Description

Kelly Science is seeking a Senior Pharmacovigilance Specialist for a growing company located in Boston, MA.

Hourly Pay: $50/hour

Shift: Monday-Friday 8am-5pm

Employment Type: Full Time; 6 month contract with possible extension

Work Model: Remote (Boston based preferred)

Job responsibilities include:

• 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.

Qualifications:

• 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.

Interested? Please apply today for immediate consideration!

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