As an Operations Specialist 1 at IQVIA, you will be responsible for reviewing, assessing, and processing safety data and information, ensuring compliance with applicable regulations, Standard Operating Procedures (SOPs), and project requirements. You will work under the guidance of senior team members, playing a critical role in pharmacovigilance activities such as collecting adverse event information, database entry, coding, and generating reports for internal and external stakeholders.
Essential Functions
- Training: Prioritize and complete assigned trainings on time.
- Pharmacovigilance: Process safety data per project requirements, including adverse event (AE) tracking, database entry, AE/product coding, narrative writing, and literature activities.
- Quality and Compliance: Ensure compliance with SOPs and project requirements while maintaining productivity and quality standards.
- Collaboration: Liaise with internal teams (e.g., project management, clinical data) and external stakeholders (e.g., investigators, medical monitors).
- Mentorship: Mentor new team members as assigned.
- Problem Solving: Identify and address quality issues and participate in project team meetings.
- Additional Duties: May include medical review of non-serious AEs/ADRs and maintaining accurate documentation of communications.
Qualifications
- Education: Bachelor’s degree in Life Sciences.
- Experience: 3-5 years of pharmacovigilance case processing and regulatory reporting.
- Skills:
- Knowledge of medical terminology and safety databases.
- Familiarity with global and local clinical research regulations.
- Strong organizational, time management, and multitasking abilities.
- Excellent attention to detail and accuracy.
- Proficiency in Microsoft Office and web-based applications.
- Strong communication and problem-solving skills.
Additional Requirements
- Flexibility to work in shifts.
- Ability to work as part of a team and independently.
- Willingness to learn new skills across safety service lines.
About IQVIA:
IQVIA is a global leader in providing clinical research services, commercial insights, and healthcare intelligence. The company connects expertise and technology to accelerate the development and commercialization of medical treatments worldwide.
