Now Hiring: Safety Aggregate Report Specialist 2 – Lifecycle Safety, IQVIA (India)
Location: Mukundapur, West Bengal
Job Type: Full-Time
Application Deadline: 28 May 2025
Apply Now: Click here to apply
About the Role
IQVIA is hiring a Safety Aggregate Report Specialist 2 to join our Lifecycle Safety team in India. In this role, you'll lead the development and delivery of safety aggregate reports, signal detection documentation, and regulatory communication—key elements in safeguarding patient safety worldwide.
As part of our global team, you'll play a vital role in pharmacovigilance and benefit-risk management, applying your knowledge across post-marketing and clinical trial products.
Key Responsibilities
Lead and author aggregate safety reports such as PBRERs/PSURs, DSURs, PADERs, RMPs, and others.
Conduct and finalize literature surveillance, identifying ICSRs and evaluating events of special interest.
Serve as Signal Management Lead, overseeing detection, validation, evaluation, and documentation of safety signals.
Prepare and review responses to regulatory authority and PRAC (Pharmacovigilance Risk Assessment Committee) inquiries.
Interface with cross-functional teams including Regulatory Affairs, Medical Writing, Clinical Research, IT, and Safety Operations.
Participate in audits, inspections, and contribute to internal process improvement.
Mentor junior team members and lead internal training as required.
Ensure adherence to GCP, GVP, ICH guidelines, and standard operating procedures.
Qualifications & Experience
Bachelor’s Degree in a scientific or healthcare discipline is required.
2–3 years of relevant experience in pharmacovigilance, aggregate reporting, or safety analytics preferred.
Deep understanding of global regulatory requirements including GCP, GVP, and ICH guidelines.
Strong knowledge of medical terminology, literature search methods, and pharmacovigilance systems.
Excellent report writing, project coordination, and documentation skills.
Proficiency in Microsoft Office (Word, Excel, PowerPoint) and web-based tools.
Ability to prioritize tasks, meet deadlines, and manage projects independently.
Strong communication, leadership, and mentoring abilities.
Why IQVIA?
IQVIA is a global leader in using data, technology, advanced analytics, and human expertise to help customers drive healthcare forward. Working at IQVIA means joining a collaborative, purpose-driven team working at the cutting edge of healthcare innovation.
We support your growth with:
A dynamic, international environment
Opportunities for upskilling and leadership
A mission-driven culture focused on improving global health outcomes
Ready to Apply?
If you're looking to grow your career in pharmacovigilance and make a real impact, this is the opportunity for you.
Join IQVIA and be part of something bigger.
Together, we help improve lives.
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