Pharmacovigilance Associate Position | JobSetuu

Description

Job Overview

• Source: RemoteOK

Job Description

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.

Expert Career Tips for Pharmacovigilance Associate Position Roles

To succeed in a competitive market as a Pharmacovigilance Associate Position , you need more than just technical skills. Here are some expert strategies to elevate your profile:

• Build a Strong Portfolio: For technical roles, a clean GitHub or a personal project site is essential. For non-technical roles, a case study portfolio demonstrating problem-solving and impact is equally valuable. Show, don't just tell, what you have achieved in your previous positions.
• Master the Narrative: When interviewing, use the STAR method (Situation, Task, Action, Result) to structure your answers. Quantify your results wherever possible—mentioning "increased efficiency by 20%" is much more impactful than saying "improved efficiency."
• Continuous Learning: The industry moves fast. Whether it's staying updated with the latest AI tools or mastering a new management methodology, continuous professional development is key. Consider obtaining industry-recognized certifications that align with Pharmacovigilance Associate Position requirements.
• Networking: Connect with other professionals in similar roles. Join online communities, attend webinars, and engage in meaningful discussions on professional social networks. Often, the best opportunities come through referrals and community engagement.
• Soft Skills Matter: Communication, empathy, and leadership are often the deciding factors between two equally qualified technical candidates. Cultivate these skills as they are universally valued across all industries and seniority levels.

Additionally, research the specific company's culture and values. Tailoring your application to show how you align with their mission can significantly increase your chances of moving forward in the process.

Salary & Compensation

Salary not disclosed; typically competitive for the role.

Work Arrangement

Type: On-Site

Standard business hours at the office.

Comprehensive Application Strategy & Hiring Process

Applying for a new role is a marathon, not a sprint. Follow this strategic approach to maximize your success rate:

1. Initial Research & Tailoring

Don't send the same resume to every employer. Spend at least 30 minutes researching the company. Look for recent news, their product roadmap, and their team structure. Modify your summary and core competencies to reflect the specific keywords found in the job description.

2. The Perfect Cover Letter

If the application allows for a cover letter, use it to tell a story that your resume cannot. Explain why you are passionate about this specific company and how your unique background makes you the perfect fit for the challenges they are currently facing.

3. Navigating the Multi-Stage Interview

Most modern hiring processes involve 3-5 stages. This typically includes a recruiter screen, a technical or skill-based assessment, a peer interview, and a final leadership round. Prepare for each stage differently: focus on enthusiasm and fit for the recruiter, technical depth for the assessment, and strategic vision for the leadership round.

4. Post-Interview Follow-Up

Always send a personalized thank-you note within 24 hours of each interview. Reference a specific topic discussed during the call to demonstrate your active listening and genuine interest in the role.

By following these steps, you demonstrate a high level of professionalism and attention to detail that sets you apart from the average applicant.

Typical Interview Process

1. Resume screening
2. HR call
3. Skill interview
4. Final manager interview
5. Offer

Tip: Research the company's products and culture.

Global Market Intelligence & Relocation Insights

At JobSetuu, we specialize in helping talent navigate the global job market. Here is what you need to know about the current landscape in Global and beyond:

The demand for skilled professionals is increasingly borderless. For roles based in Global, understanding the local cost of living, visa requirements (if applicable), and cultural nuances is vital. If this is a remote role, consider the time zone alignment and the asynchronous communication culture of the hiring organization.

Relocation Support: Many forward-thinking companies offer relocation packages that include moving stipends, temporary housing, and legal assistance with work permits. When evaluating an offer, look beyond the base salary—consider the total compensation package, including equity, bonuses, and healthcare benefits.

Work-Life Balance Trends: Hybrid and remote work have become standard in many regions. Research the local labor laws and common practices regarding work hours and vacation time to ensure the role aligns with your lifestyle goals.

Leveraging JobSetuu's tools can help you compare salaries across different cities and understand the "purchasing power" of your potential offer, ensuring you make an informed decision for your long-term career path.

Skills & Competency Roadmap for Professional Development

To remain competitive in Professional Development, we recommend focusing on the following core competencies over the next 12-18 months:

• Technical Mastery: Deepen your expertise in the core tools and languages relevant to your field. For developers, this might be cloud architecture; for marketers, it might be data-driven attribution modeling.
• AI Augmentation: Learn how to leverage generative AI and automation tools to increase your productivity. Understanding how to integrate these technologies into your workflow is becoming a non-negotiable skill.
• Leadership & Strategy: Even in individual contributor roles, the ability to think strategically and lead projects from inception to completion is highly valued. Focus on stakeholder management and high-level project planning.
• Data Literacy: The ability to interpret data and use it to drive decisions is essential across all business functions. Familiarize yourself with data visualization and basic analytical concepts.

By investing in these areas, you not only prepare yourself for the role you are applying for today but also build a resilient foundation for the opportunities of tomorrow.

Apply via JobSetuu

Discover your next career milestone on JobSetuu. This Pharmacovigilance Associate Position position is part of our commitment to bringing you the most relevant and high-impact job openings globally. At JobSetuu, we simplify your job search by aggregating premier listings and providing the tools you need to stand out. Don't miss the chance to elevate your professional journey—explore more opportunities and career insights on our platform today.