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.
Slug: operations-specialist-lifecycle-safety-bangalore
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