Pharmacovigilance Associate

Company Description
Aadya Systems develops innovative solutions that support patients and pharmaceutical organizations, with a focus on improving patient safety, access, operational efficiency, and quality of care.

Role Description
Aadya Systems is seeking Freelance Pharmacovigilance Associates to support drug safety and case-processing activities on a flexible, case-by-case basis.

This is a freelance opportunity, not a fixed-volume role. Associates can take on as many cases as they are comfortable and able to manage, based on their availability and capacity. Compensation will be provided on a per-case basis for cases successfully completed in accordance with defined quality requirements.

The role offers flexibility in workload while maintaining a strong focus on accuracy, quality, regulatory compliance, and timely completion. Freelancers will be expected to ensure that every case they accept meets the required pharmacovigilance quality standards.

Key Responsibilities

• Prepare and review clear, accurate, and clinically appropriate case narratives.
• Perform quality control (QC) of safety cases and supporting documentation.
• Review adverse event information for completeness, consistency, and accuracy.
• Perform or support medical coding using MedDRA and WHO Drug/WHO-DD.
• Enter and review safety information within pharmacovigilance databases, where applicable.
• Ensure cases are processed in accordance with applicable SOPs, quality standards, and regulatory requirements.
• Complete accepted cases within agreed timelines.
• Identify data discrepancies or quality issues and ensure appropriate resolution.
• Maintain confidentiality and appropriate handling of sensitive safety and patient information.
• Collaborate remotely with relevant stakeholders when case clarification or additional review is required.
• Contribute to continuous improvement of pharmacovigilance processes and case quality.
• Freelance Engagement Model
• 100% freelance opportunity
• Remote working
• Payment on a per-case basis
• Flexible case volume: freelancers can take on cases according to their availability and capacity
• No fixed case volume commitment, unless separately agreed
• Payment is linked to cases completed in accordance with the agreed scope and quality requirements
• All submitted work must meet defined quality, accuracy, completeness, and turnaround-time expectations
• Repeated quality issues or failure to meet agreed standards may affect allocation of future cases
• Qualifications
• Degree in Pharmacy, Life Sciences, Medicine, Nursing, or a related healthcare/scientific discipline.
• Previous experience in pharmacovigilance, drug safety, ICSR processing, medical review, or clinical research is preferred.
• Strong experience in case narrative writing and summarizing clinical information accurately.
• Experience performing quality review/QC of individual case safety reports (ICSRs) is highly desirable.
• Good understanding of pharmacovigilance principles and global safety reporting requirements.
• Knowledge of MedDRA and WHO Drug/WHO-DD coding.
• Familiarity with pharmacovigilance/safety databases is an advantage.
• Strong understanding of medical terminology, adverse events, medications, and clinical information.
• Excellent attention to detail and ability to identify inconsistencies or missing information.
• Ability to independently manage workload and meet agreed case timelines.
• Strong written English communication skills.
• Comfortable working independently in a remote freelance environment.