Los Angeles, Los Angeles, California, United States1 day ago
NewMarketingfull-timemidAggregator
Salary
$0–0/yr
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 Professional Experience
1â2 years of experience in drug safety/pharmacovigilance, including hands-on ICSR case processing.
Experience in safety databases, including end-to-end case workflow (intake through submission/distribution), case follow-up, and data quality activities.
Working knowledge of global PV regulations and guidelines (e.g., ICH E2A/E2B(R3)/E2D; FDA/EMA reporting concepts) and pharmacovigilance SOPs.
Experience with medical coding conventions and safety data quality practices.
Strong attention to detail, ability to follow procedures, and commitment to data integrity and compliance.
Proficient written and verbal communication skills; ability to summarize case information clearly in narratives.
Ability to manage multiple priorities and meet timelines in a high-volume environment.
Bachelorâs degree in life sciences, pharmacy, nursing, public health, or a related field (or equivalent experience).
Preferred Education And Experience
Experience with safety data reconciliation (clinical vs. safety), partner data exchange, and/or case distribution workflows.
Familiarity with safety reporting gateways and E2B(R3) transmission concepts.
Experience supporting periodic reporting activities (e.g., DSUR/PSUR/PBRER support tasks) or signal detection support tasks.
Prior experience working with vendors/CROs and case processing metrics/KPIs.
Experience in a GxP environment with exposure to audits/inspections.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job.Duties, responsibilities and activities may change at any time with or without notice.
Position Type/Expected Hours of Work
This is a full-time position. Days and hours of work are Monday through Friday, approximately 8:30 AM to 5 PM, depending on the schedule for the day. This position occasionally requires