Senior Pharmacovigilance Specialist

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! Apply tot his job Apply tot his job