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Operations Specialist 1 - India

3+ years
Not Disclosed
10 May 9, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Operations Specialist 1 - India
Department: Lifecycle Safety
Location: Bengaluru, Karnataka
Job Type: Full-Time
Application End Date: 09 May 2025


Job Overview:

As an Operations Specialist 1 in the Lifecycle Safety department, you will be responsible for reviewing, assessing, and processing safety data from multiple sources. You will work under the guidance of senior team members to ensure compliance with applicable regulations, SOPs, and project-specific guidelines.


Essential Functions:

  • Complete all assigned training within deadlines.

  • Process safety data (e.g., adverse events) per regulatory and project requirements.

  • Perform pharmacovigilance tasks such as:

    • Tracking incoming safety information

    • Determining initial/update status of events

    • Entering data into databases

    • Coding AEs and products

    • Writing narratives and handling literature-based activities

  • Meet project-defined quality and productivity standards.

  • Maintain full compliance with project protocols and SOPs.

  • Read, acknowledge, and comply with all relevant SOPs and training plans.

  • Manage safety case creation, maintenance, and tracking per project plan.

  • Identify and escalate quality concerns to senior staff.

  • Collaborate with internal teams and external stakeholders (e.g., medical monitors, investigators).

  • Mentor new team members if assigned.

  • Attend team meetings and share operational feedback.

  • Perform medical review of non-serious AEs and ADRs if project requires.

  • Lead or support departmental initiatives as assigned.

  • Ensure 100% adherence to people-related practices and processes.


Qualifications & Skills:

  • Education & Experience:

    • High School Diploma or equivalent in a scientific or healthcare discipline

    • Bachelor’s degree in life sciences or related field preferred

    • Up to 3 years of relevant experience, including up to 1 year in Pharmacovigilance

  • Technical & Functional Skills:

    • Knowledge of medical terminology and global clinical regulatory standards

    • Familiarity with Safety Databases and Microsoft Office tools

    • Strong communication, organizational, and time-management skills

    • Ability to handle multiple priorities and meet strict deadlines

    • Demonstrated ability to follow processes and work independently

    • Willingness to learn new skills across safety service lines

    • Flexibility to operate in shift-based work environments

    • Commitment to high-quality work and collaboration with team members


Company Profile:
IQVIA is a global leader in clinical research, analytics, and technology solutions, dedicated to transforming healthcare. The company helps clients bring innovative medical treatments to market and improve patient health outcomes. Visit
jobs.iqvia.com to learn more.


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