IQVIA, a global leader in clinical research and healthcare intelligence, is hiring an Operations Specialist for their Kolkata office. This full-time position.
About IQVIA
IQVIA is at the forefront of providing clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. With a commitment to improving patient outcomes and advancing medical treatments, IQVIA creates intelligent connections across the globe. Discover more about IQVIA
here.
Job Overview
As an Operations Specialist at IQVIA in Kolkata, you will play a crucial role 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 trainings 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 initial/update status of incoming events
- database entry
- coding AE and Products, writing narratives, Literature related activities as per internal/ project timelines.
- Ensure to meet quality standards per project requirements.
- Ensure to meet productivity and delivery standards per project requirements.
- To ensure compliance to all project related processes and activities.
- Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. 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 client in relation to details on day to day case processing activities.
- To mentor new teams members, if assigned by the Manager.
- Attend project team meetings and provide feedback to operations manager 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 above mentioned responsibilities, depending on the project requirement, the team member may perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal of AE coding, past medical history, concomitant medications, expectedness/ listedness, 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.
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IQVIA Pharmacovigilance Vacancies | Operations Specialist in Kolkata[/caption]
Qualifications
- Education: Bachelor’s degree in life sciences.
- Experience: 3-5 years in pharmacovigilance case processing and regulatory reporting.
- Good knowledge of medical terminology. Intermediate
- Working knowledge of applicable Safety Database and any other internal/Client applications. Intermediate
- Knowledge of applicable global, regional, local clinical research regulatory requirements. Intermediate
- Excellent attention to detail and accuracy. Intermediate
- maintain high quality 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 strict deadlines, 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, contribute and work towards achieving Team goals. Intermediate
- Ensure quality of deliverables according to the agreed terms. Intermediate
- Demonstration of IQVIA core values while doing daily tasks Advanced
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Intermediate
- Regular sitting for extended periods of time. Intermediate
- May require occasional travel. Intermediate
- Flexibility to operate in shifts. IntermediateSkills
Location
- Office: Kolkata, West Bengal, India.
Apply Now
Ready to take the next step in your career? Apply for the Operations Specialist position at IQVIA in Kolkata by clicking
here.
https://pharmastuff.org.in/job/iqvia-pharmacovigilance-operations-specialist
