IQVIA Pharmacovigilance Vacancies | Operations Specialist

IQVIA, a global leader in clinical research and healthcare intelligence, is hiring a full-time Operations Specialist for its Kolkata office.

About IQVIA

IQVIA provides clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. Committed to improving patient outcomes and advancing medical treatments, IQVIA creates intelligent connections across the globe.

Job Overview

As an Operations Specialist at IQVIA in Kolkata, you will be crucial in reviewing, assessing, and processing safety data and information. Your responsibilities will span various service lines and involve distributing reports/data to internal and external parties in compliance with regulations and internal guidelines.

Key Responsibilities

• To Prioritize and complete the assigned training on time.
• Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
• To perform Pharmacovigilance activities per project requirement, including but not limited to  collecting and tracking incoming  – Adverse Events(AE)/endpoint information
• determining the initial/update status of incoming events
• database entry
• Coding AE and Products, writing narratives, and doing literature-related activities as per internal/ project timelines.
• Ensure that quality standards are met per project requirements.
• Ensure that productivity and delivery standards are met per project requirements.
• To ensure compliance with all project-related processes and activities.
• Read and acknowledge all required IQVIA standard operating procedures (SOPs) and customer SOPs. Ensure all the necessary training is executed and documented in a timely fashion. Work towards ensuring your individual training plan and training transcript are reconcilable.
• Creating, maintaining and tracking cases as applicable to the project plan.
• Identify quality problems, if any, and bring them to the attention of a senior team member. To demonstrate problem-solving capabilities.
• Liaise with different functional team members, e.g. project management, clinical, data management
• health care professionals, e.g. investigators, medical monitors, site coordinators and designees, to address project-related issues.
• May liaise with clients about details on day-to-day case processing activities.
• Mentor new team members if assigned by the Manager.
• Attend project team meetings and provide feedback to other operations managers on any challenges/issues or successes.
• Perform other duties as assigned.
• Lead/ Support department Initiatives100% compliance towards all people practices and processes
• In addition to the responsibilities mentioned earlier, depending on the project requirement, the team member may perform a medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs), which includes reviews of AE coding, past medical history, concomitant medications, expectedness/listed ness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications.

Qualifications

• Education: Bachelor’s degree in science: Bachelor’s degree in life science and up to 3 years of relevant experience, including up to 1 year of Pharmacovigilance experience. Req
• Working knowledge of applicable Safety Databases and any other internal/Client applications. Intermediate
• Knowledge of applicable global, regional, and local clinical research regulatory requirements. Intermediate
• Excellent attention to detail and accuracy. Intermediate
• maintainshigh-qualityy standards. Intermediate
• Good working knowledge of Microsoft Office and web-based applications. Intermediate
• Strong organizational skills and time management skills. Intermediate
• Strong verbal/written communication skills. Intermediate
• Self-motivated and flexible. Intermediate
• Ability to follow instructions/guidelines, utilize initiative and work independently. Intermediate
• Ability to multi-task, meet deadlines, and manage competing priorities and changing demands. Intermediate
• Ability to delegate to less experienced team members. Intermediate
• Ability to be flexible and receptive to changing process demands. Intermediate
• Willingness and aptitude to learn new skills across Safety service lines. Intermediate
• Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Intermediate
• Ability to work as a Team Player and contribute to achieving Team goals. Intermediate
• Ensure the quality of deliverables is met according to the agreed terms. Intermediate
• Demonstrate IQVIA core values while doing daily tasks. Advanced
• Extensive use of telephone and face-to-face communicationrequiresg accurate perception of speech. Intermediate
• Regular sitting for extended periods. Intermediate
• It may require occasional travel. Intermediate
• Flexibility to operate in shifts. IntermediateSkills

Location

• Office: Pune, Mahārāshtra

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