Puma Biotechnology Inc. does not accept unsolicited resumes or candidates from outside staffing agencies or recruiters.
We are seeking a Pharmacovigilance Associate with 1–2 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
- 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.
- Ability 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).
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 working outside of these hours, and may extend to evenings and weekends as business needs require.
Work Environment
This position operates in a professional, virtual environment, working from a remote location, usually the employee’s home. This position may require working across time zones to support global case processing timelines. The role involves routine computer-based work and sustained attention to detail while processing confidential safety information.
Travel
The role requires infrequent travel. Minimal travel may be required for meetings and/or conferences, up to 5%.
Physical Demands
This is a remote position with employees working from a home office. The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position. The physical demands of the home office are normally associated with extended amounts of time sitting and using office equipment (including a computer, keyboard, and mouse), standing, walking, sitting, speaking, and hearing. The employee must occasionally lift or move up to 25 pounds.
Compensation Range
The salary range for this role is $70,000 – $85,000 per year. Higher compensation may be available for someone with advanced skills and/or experience.
At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), 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.
Puma Biotechnology Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, status as a protected veteran, or any other characteristic protected by law.
