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Are you a skilled professional in pharmacovigilance looking to make a difference in patient safety? IQVIA, a global leader in clinical research and healthcare intelligence, is hiring an Operations Specialist 2 for our Lifecycle Safety team in Mukundapur, West Bengal, India. Join us to leverage your expertise in a full-time role and contribute to innovative medical solutions!
About IQVIA
IQVIA is a trusted partner in the life sciences and healthcare industries, delivering clinical research services, commercial insights, and healthcare intelligence. Our mission is to accelerate the development of life-changing treatments and improve patient outcomes worldwide. Learn more at jobs.iqvia.com.
Job Overview
As an Operations Specialist 2, you’ll apply your expertise to review, assess, and process safety data across service lines. This role involves complex decision-making, mentoring junior staff, and overseeing small to medium operational projects in pharmacovigilance.
Position Details
| Field | Details |
|---|---|
| Role | Operations Specialist 2 – Lifecycle Safety |
| Location | Mukundapur, West Bengal, India |
| Job Type | Full-Time |
| Application End Date | March 23, 2025 |
Key Responsibilities
Here’s what you’ll do in this role:
- Safety Data Processing:
- Process safety data per regulations, SOPs, and project requirements.
- Collect, track, and process adverse events (AEs) and endpoint information.
- Perform database entry, AE/product coding, narrative writing, and quality reviews.
- Assist with case reconciliation, closure, and translations per timelines.
- Regulatory Reporting:
- Assess safety data for reportability and submit to authorities, ethics committees, and investigators within deadlines.
- Liaise with stakeholders for expedited reporting and regulatory tracking.
- Leadership & Mentorship:
- Mentor junior team members and provide training on technical/process issues.
- Act as a backup for the Operations Manager when needed.
- Lead or contribute to deliverables in safety publishing, risk management, or surveillance.
- Project Management:
- Maintain project files, templates, databases, and workflows.
- Provide feedback on project metrics, challenges, and successes to stakeholders.
- Participate in team meetings and working groups to improve processes.
- Compliance & Quality:
- Ensure compliance with IQVIA SOPs, client SOPs, and training requirements.
- Maintain high-quality standards and support audit preparedness.
- Medical Review (if applicable):
- Conduct medical reviews of non-serious AEs/ADRs, including coding, causality assessment, and documentation.
Qualifications
We’re looking for candidates with the following:
- Education:
- Bachelor’s degree in a scientific or healthcare discipline (e.g., life sciences) required.
- Up to 5 years of relevant experience, including 3 years in pharmacovigilance, or equivalent combination of education/training preferred.
- Skills & Knowledge:
- Excellent knowledge of medical terminology and safety databases.
- In-depth understanding of global and local clinical research regulations.
- Strong project management, leadership, and mentoring skills.
- Proficiency in Microsoft Office and web-based applications.
- Personal Attributes:
- Advanced communication (verbal/written), problem-solving, and critical thinking skills.
- Ability to multitask, meet deadlines, and work independently or as a team player.
- Flexibility to work in shifts and adapt to changing priorities.
Why Join IQVIA?
At IQVIA, you’ll work with a global leader committed to innovation and excellence. This role offers:
- Opportunities to mentor and lead within a collaborative team.
- Exposure to cutting-edge pharmacovigilance processes.
- A chance to contribute to patient safety and population health worldwide.
Location Spotlight: Mukundapur, West Bengal
Our office in Mukundapur, Kolkata, provides a vibrant and supportive work environment in one of India’s key healthcare hubs.
How to Apply
Ready to join us? Applications are open until March 23, 2025. Visit jobs.iqvia.com to submit your resume and explore this opportunity further.
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Apply Here (Referred By: Shruti Shaw)
Note: Ensure 100% compliance with IQVIA’s people practices and processes during the application process.
Referred By: Shruti Shaw
Take the Next Step
Join IQVIA as an Operations Specialist 2 and help shape the future of healthcare. Apply today and be part of a team that drives intelligent connections for a healthier world!
