Job Title: Operations Specialist I – Pharmacovigilance
Locations: Bangalore, Kolkata, Thane, India
Employment Type: Full-Time
Experience Required: 0–3 years in pharmacovigilance or clinical operations; candidates with less than 30 days notice period preferred
About the Role:
IQVIA is seeking an Operations Specialist I to support the processing and management of safety data across multiple service lines. This role involves accurate data handling, compliance with global and local regulatory requirements, and collaboration with cross-functional teams including clinical, data management, and medical affairs. The Operations Specialist will contribute to high-quality pharmacovigilance operations that support patient safety and regulatory compliance.
Key Responsibilities:
Review, assess, and process safety data and adverse event (AE) information according to SOPs, regulatory guidelines, and project requirements.
Perform pharmacovigilance activities including AE/endpoint collection, status determination, database entry, AE/product coding, narrative writing, and literature activities.
Ensure high-quality standards, productivity, and timely delivery of assigned tasks.
Maintain and track cases, ensuring completeness and accuracy of safety data.
Liaise with internal teams (project management, clinical, data management) and external stakeholders (investigators, medical monitors, site coordinators) to resolve project-related issues.
Attend project meetings and provide feedback to operations managers on challenges or successes.
Mentor new team members and provide guidance on standard procedures.
Support department initiatives and contribute to process improvements.
Conduct medical review of non-serious AEs/ADRs when applicable, ensuring accurate coding, causality assessment, and regulatory compliance.
Maintain documentation for all communications and ensure adherence to company quality policies.
Qualifications & Skills:
Bachelor’s degree in scientific, healthcare, or allied life sciences discipline.
Up to 3 years of experience in pharmacovigilance, clinical research, or related fields.
Knowledge of medical terminology and pharmacovigilance databases (LSMV/ArisG preferred).
Understanding of global, regional, and local clinical research regulatory requirements.
Proficiency in Microsoft Office and web-based applications.
Strong attention to detail, organizational skills, and time management.
Effective verbal and written communication skills.
Ability to multitask, prioritize, and meet strict deadlines in a dynamic environment.
Self-motivated, flexible, and capable of independent work as well as team collaboration.
Willingness to work in shifts and occasional travel if required.
Why Join IQVIA:
Work with a leading global provider of clinical research services, commercial insights, and healthcare intelligence.
Contribute to innovative projects that improve patient outcomes and advance healthcare solutions worldwide.
Opportunities for professional growth, cross-functional exposure, and skill development.
Collaborative and inclusive work environment with flexible work arrangements.
About IQVIA:
IQVIA connects data, technology, advanced analytics, and domain expertise to help healthcare organizations develop innovative medical treatments. With global operations and industry-leading capabilities, IQVIA accelerates clinical research, supports commercialization strategies, and improves patient outcomes worldwide. Learn more at https://jobs.iqvia.com.
How to Apply:
Submit your resume to join a dynamic pharmacovigilance team contributing to global patient safety and healthcare innovation.
#Hiring #OperationsSpecialist #Pharmacovigilance #ClinicalOperations #LifeSciences #IQVIA #BangaloreJobs #KolkataJobs #ThaneJobs
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