Adverse Events Reporting Associate (Pharmacovigilance)
Description: The Adverse Events Reporting Associate (Pharmacovigilance) supports KJT’s compliance function by performing the intake, documentation, and submission of Adverse Events (AEs) and Product Complaints (PCs) identified during market research activities. This role ensures timely and accurate case handling in accordance with client requirements and internal procedures. This is an early-career position ideal for individuals with strong attention to detail, excellent written communication, and an interest in drug safety, research compliance, or healthcare operations. Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Other duties and projects may also be assigned. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential job functions. Adverse Event Intake & Screening
- Review transcripts, survey data, call notes, and vendor communications to identify potential AEs/PCs.
- Validate cases against client-defined criteria and escalate unclear items to the Manager.
- Maintain clear and concise AE notes and summaries.
Documentation & Submission
- Complete client-specific AE/PC reporting forms accurately.
- Submit AEs within required timelines (e.g., 24-hour windows).
- Track submissions and monitor follow-up or clarification requests.
- Maintain organized documentation for audit readiness.
Compliance Support
- Maintain internal AE/PC logs and trackers.
- Ensure all documentation meets accuracy and quality standards.
- Follow internal procedures related to data privacy and handling sensitive information.
- Support audit preparation by gathering required documentation.
Cross-Functional Support
- Communicate with project teams regarding AE requirements and missing information.
- Assist the Manager with training logistics or process updates as needed.
- Attend internal project kickoffs to understand AE criteria for new clients.
Information Security Management The individual in this role is responsible for maintaining compliance with the KJT Group Information Security Policy and all other policies, processes, and documentation related to information security within KJT Group. Requirements: Key Competencies for Success
- Strong written communication
- Excellent attention to detail
- Strong organization and time management
- Calm and accurate under tight timelines
- Professional judgment in interpreting participant statements
- Ability to follow structured procedures consistently
- Collaborative communication across teams
Education/Experience:
- Bachelor’s degree in life sciences, psychology, public health, healthcare, market research, or related field preferred.
- Experience in PV, drug safety, research, healthcare, or quality processes (internships acceptable).
- Basic understanding of adverse events and safety reporting concepts.
Preferred Qualifications
- Experience working in a market research or patient/consumer research environment (can be an internship).
- Familiarity with AE/PV terminology and processes.
- Understanding of regulatory frameworks (FDA, EMA, MHRA, PMDA).
- Knowledge of GDPR principles or willingness to learn quickly.
- Experience with documentation, compliance logs, or standardized forms.
Computer Skills:
- Microsoft Office Suite (Word, Excel, PowerPoint and Outlook)
Additional Information
- May occasionally require weekend or holiday availability depending on client reporting timelines.
- Requires daily monitoring of multiple projects with varying criteria.
- Must be highly organized and able to manage their workflow independently while keeping the Manager informed.
KJT Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.