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

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

**Key duties / responsibilities**
– Process adverse drug reactions (AEs) and cases from special situations in the safety database (intake, triage, data entry, follow-up, narrative creation, coding, and quality review) according to SOPs and applicable regulations.
– Perform medical coding using MedDRA and WHO Drug (or company-specific dictionaries); support dictionary updates and, when needed, related quality checks.
– Ensure timely regulatory reporting and distribution activities (if applicable), including assessment of case seriousness, expectedness, and reportability per established procedures.
– Conduct case quality controls (QC), handle data queries, document decisions, and maintain records that are inspection-ready.
– Support activities in the safety database, such as case lifecycle management, assistance with duplicate search/merge, data cleansing, and monitoring workflow.
– Reconcile safety information with clinical, medical, product quality, and/or partner sources; investigate inconsistencies and support periodic reconciliation deliverables.
– Track operational metrics (throughput, timeliness, quality), identify root causes of trends, and recommend process improvements.
– Collaborate cross-functionally with Clinical Operations, Medical Affairs, Quality, Regulatory, and vendors/partners to obtain follow-up information, resolve data queries, and ensure consistent safety data capture.
– Support inspections/audits by ensuring proper documentation and responding to requests under oversight.
– Contribute to maintaining and continuously improving pharmacovigilance processes, templates, and work instructions.
– Support cross-functional safety data review meetings, including distributing meeting materials and preparing/finalizing meeting minutes.

**Required competencies**
– Quality-minded approach and strong compliance orientation
– Analytical thinking and sound judgment within defined guidelines
– Ownership, accountability, and reliability in meeting deadlines
– Strong teamwork and collaboration skills across functions and global teams
– Clear skills in documentation and communication

**Required education and experience**
– 1–2 years of experience in drug safety/pharmacovigilance, including hands-on processing of ICSR cases.
– Experience with safety databases, including end-to-end case workflow (from intake through submission/distribution), case follow-up, and activities supporting data quality.
– Strong knowledge of global PV regulations and guidance (e.g., ICH E2A/E2B(R3)/E2D; concepts for FDA/EMA reporting) as well as pharmacovigilance SOPs.
– Experience applying medical coding conventions and safety data quality assurance practices.
– Excellent attention to detail; ability to follow procedures; commitment to data integrity and compliance.
– Proficiency in written and verbal communication, including clear summarization of case information in narratives.
– Ability to manage multiple priorities and meet deadlines in a high-volume case environment.
– Bachelor’s degree in life sciences, pharmacy, nursing, public health, or a related field (or equivalent experience).

**Preferred education and experience**
– Experience reconciling safety data (clinical vs. safety-relevant), exchanging data with partners, and/or working within case distribution workflows.
– Familiarity with safety reporting gateways and E2B(R3) submission concepts.
– Experience supporting periodic reporting activities (e.g., DSUR/PSUR/PBRER support) or signal detection-related tasks.
– Prior experience working with vendors/CROs and contributing to case processing metrics/KPIs.
– Experience in a GxP environment, including exposure to audits/inspections.

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

**Employment type / expected working hours**
This is a full-time position. Workdays are Monday through Friday, approximately 8:30 a.m. to 5:00 p.m., depending on the daily schedule. Occasional work outside these hours may be required and may include evenings and weekends if business needs require it.

**Work environment**
This role is performed in a professional virtual environment, where employees work remotely from a location such as home. Working across time zones may be required to support global case processing schedules. The role includes routine computer-based tasks and ongoing attention to detail when handling confidential safety information.

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

**Physical requirements**
This remote role is performed from a home office. The physical requirements described are those required to perform the primary job functions. Typical tasks include prolonged sitting and use of office equipment (computer, keyboard, and mouse), as well as standing, walking, speaking, and hearing. The employee may occasionally be required to 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 candidates with advanced skills and/or relevant experience.

At Puma Biotechnology, we offer a competitive compensation package including a base salary, an annual bonus target amount, and a comprehensive benefits package. Individual compensation will depend 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.