Job Description
Note: The job is a remote job and is open to candidates in USA. Kelly 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. 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 Skills • 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 Overview • Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom. It was founded in 1946, and is headquartered in Troy, Michigan, USA, with a workforce of 5001-10000 employees. Its website is Apply tot his job