Pharmacovigilance Associate Position
WFA Digital Insight
The demand for pharmacovigilance professionals has skyrocketed in recent years, with a 25% increase in job postings in 2025 alone. As the pharmaceutical industry continues to evolve, companies like Puma Biotechnology are seeking skilled professionals to ensure compliance with global regulatory requirements. With the shift to remote work, this role offers a unique opportunity for pharmacovigilance professionals to work with a leading biotechnology company. Candidates should be prepared to showcase their expertise in safety databases and regulatory requirements, as well as their ability to work collaboratively in a remote environment.
Job Description
About the Role
The Pharmacovigilance Associate will play a critical role in supporting case processing activities and safety operations at Puma Biotechnology. This role will be responsible for ensuring timely, accurate, and compliant Individual Case Safety Report (ICSR) intake, processing, reporting, and reconciliation in accordance with global regulatory requirements and company procedures. The ideal candidate will have a strong understanding of pharmacovigilance principles and regulatory requirements, as well as excellent analytical and communication skills.As a key member of the pharmacovigilance team, the Associate will work closely with cross-functional teams, including Clinical Operations, Medical Affairs, Quality, and Regulatory, to ensure that safety data is accurately collected, processed, and reported. This role will also involve collaborating with vendors and partners to obtain follow-up information and resolve queries.
The Pharmacovigilance Associate will be working in a fast-paced environment, with multiple priorities and deadlines. Therefore, the ability to manage multiple tasks, prioritize work, and meet timelines is essential.
What You Will Do
- Process adverse events (AE) and special situation cases, including intake, triage, data entry, follow-up, narrative writing, coding, and quality review, in the safety database
- 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, 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, including 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
What We Are Looking For
- 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)
Nice to Have
- 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 regulatory inspections and audits
Benefits and Perks
- Competitive salary and benefits package
- Opportunity to work with a leading biotechnology company
- Collaborative and dynamic work environment
- Professional development and growth opportunities
- Flexible remote work arrangements
- Access to cutting-edge technology and tools
- Recognition and reward for outstanding performance
- Comprehensive health and wellness program
- Generous paid time off and holidays
How to Stand Out
- Make sure to highlight your experience with safety databases and pharmacovigilance regulations in your resume and cover letter.
- Be prepared to provide specific examples of your experience with medical coding conventions and safety data quality practices.
- Familiarize yourself with Puma Biotechnology's products and pipeline, and be prepared to discuss how your skills and experience align with the company's goals.
- Show enthusiasm and interest in the company and the role, and be prepared to ask thoughtful questions during the interview.
- Consider creating a portfolio or samples of your work to demonstrate your skills and experience in pharmacovigilance.
- Be prepared to discuss your experience with regulatory inspections and audits, and how you have ensured compliance with regulatory requirements in your previous roles.
This is a remote position listed on WFA Digital, the platform for professionals who work from anywhere. Browse more remote jobs across all categories.