Review, assess, and process safety data and information across service lines. Distribute reports/data to both internal and external third parties following applicable regulations, SOPs, and internal guidelines with guidance from senior operation team members.
Essential Functions:
- Prioritize and complete assigned training on time.
- Process safety data according to regulations, guidelines, SOPs, and project requirements.
- Perform pharmacovigilance activities including collecting and tracking Adverse Events (AE)/endpoint information.
- Determine the initial/update status of incoming events.
- Database entry, AE and product coding, narrative writing, and literature-related activities as per timelines.
- Meet quality standards and project requirements.
- Ensure compliance with project-related processes and activities.
- Read and acknowledge IQVIA and customer SOPs; execute and document required training.
- Create, maintain, and track cases according to the project plan.
- Identify and report quality problems.
- Demonstrate problem-solving capabilities.
- Liaise with functional team members, healthcare professionals, and clients on case processing activities.
- Mentor new team members if assigned by the manager.
- Attend project team meetings and provide feedback.
- Perform other duties as assigned.
- Lead/support department initiatives.
- Ensure 100% compliance with all people practices and processes.
- Depending on project requirements, may perform medical review of non-serious AEs and ADRs, including AE coding, causality assessment, and ensuring data accuracy and completeness.
Qualifications:
- Experience: 2-5 years in pharmacovigilance case processing.
- Education: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field.
- Skills:
- Good knowledge of medical terminology.
- Working knowledge of safety databases and client applications.
- Knowledge of global, regional, and local clinical research regulatory requirements.
- Excellent attention to detail and accuracy.
- Strong organizational, time management, and communication skills.
- Proficiency in Microsoft Office and web-based applications.
- Ability to follow instructions, work independently, multitask, meet deadlines, manage competing priorities, and adapt to changing demands.
- Team player with the ability to establish effective communication and working relationships.
- Commitment to high-quality deliverables and IQVIA core values.
- Willingness to learn new skills and flexibility to operate in shifts.
- May require occasional travel.
