Job Title: Operations Specialist 1
Department: Lifecycle Safety
Location: Bangalore, India
Job Type: Full-Time
End Date to Apply: 9 May 2025
Job Overview:
The Operations Specialist 1 will support lifecycle safety operations by reviewing, assessing, and processing safety data from various sources. Working under the guidance of senior team members, this role ensures compliance with applicable regulations, internal SOPs, and project-specific requirements.
Key Responsibilities:
Prioritize and complete assigned training programs within deadlines.
Process safety data in accordance with regulations, SOPs, and project-specific guidelines.
Perform pharmacovigilance tasks such as:
Collecting and tracking Adverse Events (AEs) or endpoint data
Determining initial or update status of events
Database entry and coding of AEs and products
Writing narratives and conducting literature-related activities
Ensure quality and productivity standards are consistently met.
Maintain compliance with all project protocols and activities.
Read, acknowledge, and comply with all IQVIA and client SOPs.
Create, track, and maintain case records in alignment with project plans.
Identify and report any quality concerns to senior team members.
Liaise with internal and external teams including clinical, data management, and healthcare professionals.
Potentially mentor new team members as assigned.
Attend team meetings and report issues, challenges, or successes.
Support departmental initiatives and maintain 100% compliance with all people-related processes.
As required by the project, may conduct medical reviews of non-serious AEs and ADRs including:
Coding review
Assessing past medical history, medications, causality, and expectedness
Ensuring data completeness and accuracy
Qualifications:
High School Diploma or equivalent in a scientific or healthcare discipline (required)
Bachelor’s degree in Life Sciences or related field with up to 3 years of relevant experience, including at least 1 year in Pharmacovigilance (preferred)
Equivalent education and experience combinations may be considered
Skills and Competencies:
Strong understanding of medical terminology
Proficient in safety databases and client/internal applications
Knowledge of clinical research regulatory requirements
Excellent attention to detail and quality standards
Proficiency in Microsoft Office and web tools
Strong organizational, communication, and time management skills
Self-motivated with the ability to follow guidelines and work independently
Capable of multitasking, meeting deadlines, and managing shifting priorities
Strong team player with good delegation and collaboration skills
Willingness to learn new skills and adapt to changes
Must demonstrate IQVIA's core values and maintain effective relationships
Other Requirements:
Comfortable with extended periods of sitting and regular use of telecommunication
May require occasional travel and shift flexibility
About IQVIA:
IQVIA is a global leader in clinical research services, healthcare data analytics, and real-world insights. The company partners with life sciences and healthcare industries to drive innovation and improve global health outcomes. Learn more at IQVIA Careers
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