IQVIA Pune Hiring Operations Specialist | ₹4,00,000 - ₹6,00,000

Job Overview

Review, assess and process safety data and information from various sources across service lines. Distribute reports and data to internal and external third parties, following applicable regulations, Standard Operating Procedures (SOPs) and internal guidelines, under the guidance and support of senior operations team members.

Essential Functions

• Complete assigned trainings on time.
• Process safety data according to applicable regulations, guidelines, SOPs and project requirements.
• Perform pharmacovigilance activities per project requirements, including collecting and tracking incoming adverse events (AE) and endpoint information.
• Determine initial or update status of incoming events.
• Carry out database entry, AE and product coding, narrative writing and literature-related activities within internal and project timelines.
• Meet quality, productivity and delivery standards set by the project.
• Ensure compliance with all project-related processes and activities.
• Read and acknowledge all required IQVIA SOPs and customer SOPs. Complete required training in a timely fashion and document it, keeping your individual training plan and training transcript reconcilable.
• Create, maintain and track cases as per the project plan.
• Identify quality problems and escalate them to a senior team member.
• Demonstrate problem-solving capabilities.
• Liaise with functional team members (project management, clinical, data management) and healthcare professionals (investigators, medical monitors, site coordinators and designees) to address project issues.
• Liaise with the client on day-to-day case processing details where needed.
• Mentor new team members if assigned by the Manager.
• Attend project team meetings and give feedback to the operations manager on challenges, issues or successes.
• Perform other duties as assigned.
• Lead or support department initiatives.
• Maintain 100% compliance with all people practices and processes.

Depending on project requirements, you may also perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs). This includes reviewing AE coding, past medical history, concomitant medications, expectedness and listedness, causality assessment and other medical information, ensuring completeness and accuracy per applicable regulations, guidelines, SOPs and project-specific medical evaluation guidelines. Communicate with team leads on any required corrections and maintain appropriate documentation.

Qualifications

• Bachelor's degree in a scientific or healthcare discipline, or allied life sciences.
• Bachelor's degree with up to 3 years of experience, or an equivalent combination of experience, training and education.
• Good knowledge of medical terminology.
• Working knowledge of applicable safety databases and other internal or client applications.
• Knowledge of applicable global, regional and local clinical research regulatory requirements.
• Excellent attention to detail and accuracy, with a commitment to high quality standards.
• Good working knowledge of Microsoft Office and web-based applications.
• Strong organizational, time management, verbal and written communication skills.
• Self-motivated, flexible and able to work independently, follow instructions and multi-task against strict deadlines.
• Able to delegate to less experienced team members and adapt to changing process demands.
• Willingness to learn new skills across safety service lines.
• Able to build effective working relationships with coworkers, managers and clients, and contribute as a team player.
• Ensure quality of deliverables according to agreed terms.
• Demonstrate IQVIA core values in daily tasks.
• Extensive telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods, occasional travel, and flexibility to work in shifts.