Operations Specialist 1

Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members.

Key responsibilities

• Provide comprehensive safety services across the lifecycle of pharmaceutical compounds and medical devices, from first in human clinical trials through post-approval, marketed product, and regulatory safety requirements. Collect, track, and report adverse events or clinical outcomes; analyse and report aggregate safety data; perform safety surveillance; and perform benefit-risk evaluation and planning.

• Provide data gathering, entry, and reporting services on behalf of contracted customers, including both clinical trial and marketed product safety activities. Triage, track, and process safety data; assess safety data for reportability to the client safety department or relevant regulatory bodies; maintain communication (phone, fax, email) with investigative sites or marketed product reporters to obtain accurate data regarding safety events; and contribute to lifecycle safety deliverables.

• 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.

Responsibilities

• To Prioritize and complete the assigned trainings on time

• Process safety data in compliance with applicable regulations, SOPs, and project requirements.

• Perform core case processing activities, including case creation, data entry, coding, and narrative writing within defined timelines.

• Determine case status (initial/follow-up) and maintain accurate case lifecycle tracking.

• Ensure high-quality, consistent, and timely delivery aligned with project standards and productivity targets.

• Maintain compliance with internal and client procedures, including SOP acknowledgment and adherence.

• Identify and escalate quality issues or discrepancies to senior team members.

• Collaborate with cross-functional teams (e.g., clinical, data management, project teams) to resolve case-related queries.

• Communicate, as needed, with clients or stakeholders on routine case processing matters.

• Participate in team meetings and provide updates on progress, challenges, and improvements.

• Support onboarding and mentoring of new team members when assigned.

• Contribute to departmental initiatives and continuous improvement activities.

• Demonstrate problem-solving skills in day-to-day activities.

• Ensure full compliance with organizational policies and people practices.

Qualifications

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.