IQVIA Hiring in Pharmacovigilance as Operation Specialist

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.

Application Link