Pharmacovigilance Associate Position
Puma Biotechnology Inc. does not accept unsolicited resumes or candidates from outside staffing agencies or recruiters. We are seeking a Pharmacovigilance Associate with 1â2 years of pharmacovigilance experience and expert proficiency in safety databases. This role supports case processing activities and safety operations to ensure timely, accurate, and compliant Individual Case Safety Report (ICSR) intake, processing, reporting, and reconciliation in accordance with global regulatory requirements and company procedures. Major Duties / Responsibilities Process adverse events (AE) and special situation cases (intake, triage, data entry, follow-up, narrative writing, coding, and quality review) in the safety database in accordance with SOPs and applicable regulations. Perform medical coding using MedDRA and WHO Drug (or company-designated dictionaries); support dictionary upgrades and related quality checks as assigned. Ensure timely regulatory reporting and distribution activities (as applicable), including assessment of case seriousness, expectedness, and reportability per procedures. Conduct case quality control (QC) and resolve data queries; document decisions and maintain inspection-ready records. Support safety database activities: case lifecycle management, duplicates search/merge support, data cleaning, and workflow monitoring. Reconcile safety data with clinical, medical information, product quality, and/or partner sources; investigate discrepancies and support periodic reconciliation deliverables. Participate in operational metrics tracking (throughput, timeliness, quality), identifying root causes of trends and proposing process improvements. Collaborate cross-functionally with Clinical Operations, Medical Affairs, Quality, Regulatory, and vendors/partners to obtain follow-up information, query resolutions and ensure consistent safety data. Support inspections/audits by ensuring accurate documentation and responding to requests under supervision. Contribute to the maintenance and continuous improvement of pharmacovigilance processes, templates, and work instructions. Support cross-functional safety data review meeting activities including but not limited to distribution of meeting materials and completing meeting minutes. Key Competencies Quality mindset and strong compliance orientation Analytical thinking and sound judgment within defined procedures Ownership, accountability, and reliability in meeting timelines Effective collaboration in cross-functional and global teams Clear documentation and communication skills Required Education And Pr...
Score the fit and track the next step
Use the checklist as a decision aid, then keep the status and follow-up date with the saved job.
Save the job to keep this score and tracking information in your browser.
Open my full workspace →Applications are completed on the original provider's site. Review the employer and posting before sharing personal information.