Operations Specialist 1
Location: Mukundapur, West Bengal, India
Referred By: Niraj Manojsingh Thakur
Job Type: Full-Time
Key Responsibilities:
- Prioritize and complete assigned training on time.
- Process safety data according to regulations, guidelines, SOPs, and project requirements.
- Perform pharmacovigilance activities, including collecting and tracking adverse events (AE), determining status, database entry, coding AEs and products, writing narratives, and handling literature-related activities.
- Meet quality, productivity, and delivery standards per project requirements.
- Ensure compliance with project-related processes and activities.
- Read and acknowledge all required IQVIA and customer SOPs, ensuring timely execution and documentation of training.
- Create, maintain, and track cases as per the project plan.
- Identify and report quality issues to senior team members.
- Demonstrate problem-solving capabilities.
- Collaborate with functional team members and healthcare professionals to address project-related issues.
- Liaise with clients on day-to-day case processing activities.
- Mentor new team members, if assigned by the manager.
- Attend project team meetings and provide feedback on challenges or successes.
- Perform other assigned duties.
- Lead/support department initiatives.
- Ensure 100% compliance with all people practices and processes.
Additional Responsibilities (depending on project requirements):
- Perform medical reviews of non-serious adverse events (AEs) and adverse drug reactions (ADRs), ensuring completeness and accuracy of data.
- Communicate with team leads for corrections and maintain documentation.
Qualifications:
- 2-5 years of experience in pharmacovigilance case processing.
- Bachelor’s or Master’s degree in life sciences, pharmacy, or related field.
- Good knowledge of medical terminology.
- Intermediate knowledge of safety databases and client applications.
- Understanding of global, regional, and local clinical research regulatory requirements.
- Excellent attention to detail and accuracy.
- Proficient in Microsoft Office and web-based applications.
- Strong organizational and time management skills.
- Strong verbal and written communication skills.
- Self-motivated, flexible, and able to work independently.
- Ability to multi-task, meet deadlines, and manage competing priorities.
- Ability to delegate to less experienced team members.
- Receptive to changing process demands.
- Willingness to learn new skills across safety service lines.
- Ability to establish and maintain effective working relationships.
- Team player, contributing to team goals.
- Ensure quality of deliverables according to agreed terms.
- Demonstrate IQVIA core values in daily tasks.
- Extensive use of telephone and face-to-face communication.
- Regular sitting for extended periods.
- Occasional travel may be required.
- Flexibility to work in shifts.
About IQVIA:
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We push the boundaries of human science and data science to make a significant impact and help our customers create a healthier world. Learn more at IQVIA Careers.