Puma Biotechnology Inc. does not accept unsolicited resumes or candidates from individuals outside of staffing agencies or recruiters.

We are seeking a Pharmacovigilance Associate with 1–2 years of pharmacovigilance experience and advanced expertise in safety databases. This position supports case processing and safety operations to ensure timely, accurate, and compliant intake, processing, reporting, and reconciliation of Individual Case Safety Reports (ICSRs) in line with global regulatory requirements and company procedures.

**Major Duties / Responsibilities**
– Process adverse events (AEs) and special situation cases in the safety database (intake, triage, data entry, follow-up, narrative writing, coding, and quality review) according to SOPs and applicable regulations.
– Perform medical coding using MedDRA and WHO Drug (or company-designated dictionaries); support dictionary updates and related quality checks as needed.
– Ensure timely regulatory reporting and distribution activities (as applicable), including determining case seriousness, expectedness, and reportability based on established procedures.
– Conduct case quality control (QC), resolve data queries, document decisions, and maintain records ready for inspection.
– Support safety database activities such as case lifecycle management, duplicate search/merge support, data cleaning, and workflow monitoring.
– Reconcile safety information with clinical, medical, product quality, and/or partner sources; investigate discrepancies and support periodic reconciliation deliverables.
– Track operational metrics (throughput, timeliness, quality), identify root causes of trends, and recommend process improvements.
– Work cross-functionally with Clinical Operations, Medical Affairs, Quality, Regulatory, and vendors/partners to obtain follow-up information, resolve queries, and ensure consistent safety data.
– Assist with inspections/audits by ensuring accurate documentation and responding to requests under supervision.
– Help maintain and continuously improve pharmacovigilance processes, templates, and work instructions.
– Support cross-functional safety data review meetings, including distributing meeting materials and completing meeting minutes.

**Key Competencies**
– Quality-focused mindset and strong compliance orientation
– Analytical thinking and sound judgment within defined procedures
– Ownership, accountability, and dependability in meeting timelines
– Strong collaboration skills in cross-functional and global teams
– Clear documentation and communication abilities

**Required Education and Professional Experience**
– 1–2 years of experience in drug safety/pharmacovigilance, including hands-on ICSR case processing.
– Experience with 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 guidance (e.g., ICH E2A/E2B(R3)/E2D; FDA/EMA reporting concepts) and pharmacovigilance SOPs.
– Experience applying medical coding conventions and safety data quality practices.
– Strong attention to detail, ability to follow procedures, and commitment to data integrity and compliance.
– Proficiency in written and verbal communication, including clearly summarizing case information in narratives.
– Ability to manage multiple priorities and meet deadlines in a high-volume setting.
– 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) or signal detection support tasks.
– Prior experience working with vendors/CROs and case processing metrics/KPIs.
– Experience in a GxP environment, including exposure to audits/inspections.

**Other Duties**
This job description does not list every activity, duty, or responsibility required. Duties and responsibilities may change at any time, with or without notice.

**Position Type / Expected Hours of Work**
This is a full-time role. Work is Monday through Friday, approximately 8:30 AM to 5:00 PM, depending on the daily schedule. The role may occasionally require working outside these hours and could include evenings and weekends as business needs arise.

**Work Environment**
This role is performed in a professional virtual setting, working remotely from a location such as the employee’s home. It may require working across time zones to support global case processing timelines. The work involves routine computer-based tasks and sustained attention to detail while handling confidential safety information.

**Travel**
Travel is rare, and if required, it is typically limited to meetings and/or conferences—up to 5%.

**Physical Demands**
This remote role is performed from a home office. The described physical demands reflect those needed to perform the primary job functions. Tasks typically involve prolonged sitting and using office equipment (computer, keyboard, and mouse), along with standing, walking, speaking, and hearing. The employee may occasionally need to lift or move up to 25 pounds.

**Compensation Range**
The salary range for this role is $70,000–$85,000 per year. Higher pay may be available for candidates with advanced skills and/or experience.

At Puma Biotechnology, we offer a competitive compensation package that includes a base salary, an annual bonus target, and a comprehensive benefits package. Individual pay depends on experience, qualifications, location, and other job-related factors permitted by law.

Puma Biotechnology Inc. is an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, protected veteran status, or any other legally protected characteristic.

**Location**
Los Angeles, Los Angeles, California, United States.