Job Title: Pharmacovigilance Associate
Company: IQVIA
Location: Not specified
Job Overview:
The Pharmacovigilance Associate will review, assess, and process safety data and information received from various sources. This includes distributing reports and data in compliance with applicable regulations, Standard Operating Procedures (SOPs), and internal guidelines, with support from senior operation team members.
Essential Functions:
Training: Complete all required training on time and maintain a clear training transcript.
Data Processing: Process safety data in compliance with regulations, SOPs, and project requirements, including tracking incoming Adverse Events (AEs) and endpoint information, coding AEs and products, writing narratives, and handling literature activities.
Quality Assurance: Ensure data meets quality standards and project requirements. Identify any quality issues and escalate them as needed.
Case Management: Create, maintain, and track cases according to project requirements. Ensure accurate entry of case details in the safety database.
Liaison: Communicate with project management, clinical, and data management teams, and health care professionals (e.g., investigators, medical monitors, site coordinators).
Client Communication: Liaise with clients regarding day-to-day case processing activities.
Mentorship: Mentor new team members, providing guidance and support.
Collaboration: Attend project team meetings and report on challenges and successes. Support department initiatives and ensure compliance with people practices and processes.
Medical Review: May perform medical reviews of non-serious AEs and ADRs, including coding, causality assessment, and reviewing medical history, concomitant medications, and expectedness/ listedness.
Documentation: Maintain accurate documentation for all communications related to case reviews and other project activities.
Qualifications:
Education: High School Diploma or equivalent in a scientific or healthcare discipline. A Bachelor's degree in life sciences or a related field is preferred.
Experience: Up to 3 years of relevant experience, including up to 1 year in Pharmacovigilance.
Skills and Knowledge:
Knowledge of medical terminology.
Familiarity with applicable safety databases and internal/client applications.
Understanding of global, regional, and local clinical research regulatory requirements.
Strong attention to detail, time management, and organizational skills.
Proficiency with Microsoft Office and web-based applications.
Strong verbal and written communication skills.
Ability to work independently, multi-task, and meet strict deadlines.
Flexibility to work in shifts and potentially travel as required.
Working Conditions:
Extensive use of telephone and face-to-face communication.
Regular sitting for extended periods of time.
Potential for occasional travel.
Flexible work shifts may be required.
About IQVIA:
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences industry. The company strives to accelerate the development and commercialization of innovative medical treatments to improve patient outcomes globally.
For more information and to apply, visit IQVIA Careers.
Apply Now
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