Pharmacovigilance Associate - Remote Position

About the role

Puma Biotechnology Inc. is seeking a Pharmacovigilance Associate with 1–2 years of pharmacovigilance experience and expert proficiency in safety databases.

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.

Requirements

• 1–2 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.
• Able to manage multiple priorities and meet timelines in a high-volume environment.
• Bachelor’s degree in life sciences, pharmacy, nursing, public health, or a related field (or equivalent experience).

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.

Qualifications

• 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.

Benefits

This role offers an attractive compensation package including a competitive base salary, an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.