Operations Specialist 2

Project Role: Operations Specialist 2

Work Experience: 5 plus years.

Work location: Kolkata

Work Mode: Office based

Must Have Skills: ICSR case processing, argus database, Drug safety

Job Overview:

Job Responsibilities

• Process safety data per regulations, guidelines, SOPs, and project requirements.
• Perform pharmacovigilance activities including:
• Collecting and tracking Adverse Events (AEs)/endpoint information.
• Determining initial/update status of events.
• Database entry and AE/product coding.
• Writing narratives and literature-related tasks.
• Quality review, reconciliation, case closure, and translation coordination.
• Create, maintain, and track cases as per project plan.
• Perform adjudication-related activities as applicable.
• Assess safety data for reportability and report to relevant authorities within timelines.
• Liaise with stakeholders for expedited reporting and regulatory tracking.
• Contribute to or lead deliverables in Safety Publishing, Risk Management, Safety Surveillance, and Medical Information.
• Meet quality, productivity, and delivery standards.
• Ensure compliance with project processes and activities.
• Foster a collaborative team environment and mentor junior team members.
• Assist Operations Manager as needed.
• Share technical and process knowledge with Safety Management and operational teams.
• Provide oversight and understand team metrics, productivity, and initiatives.
• Maintain thorough understanding of project protocol, therapeutic indication, budget, and scope of work.
• Set up and maintain project files, templates, databases, and workflows.
• Communicate effectively with team and stakeholders on project performance and challenges.
• Provide feedback to junior team members.
• Read and acknowledge all required SOPs and complete training on time.
• Participate or lead trainings across Safety service offerings.
• Join working groups for new initiatives and process improvements.
• Demonstrate problem-solving capabilities.
• Liaise with cross-functional teams and healthcare professionals to resolve project issues.
• Attend project meetings and provide feedback to Operations Manager.
• Communicate with clients on daily activities as needed.
• Contribute to departmental goals.
• Perform other duties as assigned.
• Ensure 100% compliance with people practices and processes.
• Perform medical review of non-serious AEs/ADRs as required, ensuring data accuracy and completeness.

Technical Skills

• Excellent knowledge of medical terminology – Intermediate.
• In-depth knowledge of Safety Database and internal/client applications – Advanced.
• Strong understanding of global/regional/local clinical research regulations – Advanced.
• Excellent organizational, time management, attention to detail, and accuracy – Advanced.
• Maintain high quality standards – Advanced.
• Proficient in Microsoft Office and web-based applications – Intermediate.
• Effective project management and leadership skills – Intermediate.
• Strong mentoring and coaching abilities – Advanced.
• Excellent verbal and written communication – Advanced.
• Self-motivated, flexible, and adaptable to process changes – Advanced.
• Willingness to learn new skills across Safety service lines – Advanced.
• Ability to work independently within policies and practices – Advanced.
• Capable of multitasking, meeting deadlines, and managing priorities – Advanced.
• Skilled in task prioritization and delegation – Advanced.
• Effective communication and relationship-building with coworkers, managers, and clients – Advanced.
• Team player with a focus on team goals – Advanced.
• Sound judgment and decision-making – Advanced.
• Ability to manage multiple projects and team priorities – Intermediate.
• Ensure deliverable quality per agreed terms – Advanced.
• Demonstrate IQVIA core values in daily tasks – Advanced.
• Plan workload based on capacity and adjust priorities – Intermediate.
• Negotiate and find satisfactory solutions for stakeholders – Intermediate.
• Support audit preparedness – Advanced.
• Effective use of telephone and face-to-face communication – Intermediate.
• Ability to sit for extended periods – Intermediate.
• Willingness to travel occasionally – Intermediate.
• Flexibility to work in shifts – Advanced.