IQVIA is a global leader in providing advanced analytics, technology solutions, and clinical research services to the life sciences industry. With a focus on accelerating drug development and improving patient outcomes, IQVIA supports pharmaceutical, biotech, and medical device companies in bringing innovative treatments to market. Learn more at IQVIA Careers.
1. Regulatory Affairs Specialist – Bangalore
Job Type: Full-Time
End Date: 13th May 2025
Location: Bengaluru, Karnataka
Job Description:
As a Regulatory Affairs Specialist at IQVIA, you will act as a Regulatory Team Leader for complex projects, ensuring compliance with global regulatory standards. Your role will involve preparing and reviewing regulatory documents, managing client relationships, and providing expertise in Chemistry, Manufacturing & Controls (CMC), Lifecycle Maintenance, and Labeling.
Key Responsibilities:
- Lead regulatory submissions and documentation for assigned projects.
- Serve as a Subject Matter Expert (SME) in regulatory processes.
- Review and approve regulatory documents (e.g., marketing authorization transfers, labeling).
- Guide junior team members and assist in training.
- Participate in client meetings and bid defense presentations.
Qualifications:
- Bachelor’s or Master’s degree in Life Sciences or related field.
- 3-4 years of regulatory affairs experience in pharmaceuticals/CROs.
- Strong knowledge of R&D processes (CMC, preclinical, clinical).
- Excellent communication and organizational skills.
- Proficiency in Microsoft Office & regulatory publishing tools.
2. Sr. Medical Safety Advisor – Thane
Job Type: Full-Time
End Date: 30th May 2025
Location: Thane, Maharashtra
Job Description:
The Senior Medical Safety Advisor will provide medical expertise in pharmacovigilance, reviewing serious adverse events (SAEs), ensuring compliance with global safety regulations, and contributing to aggregate safety reports (DSUR, PBRER, RMP).
Key Responsibilities:
- Perform medical review of AEs/ADRs (coding, causality, expectedness).
- Prepare Analyses of Similar Events (AOSE) for expedited reports.
- Support signal detection and risk management plans (RMPs).
- Lead safety surveillance activities and regulatory submissions.
- Provide 24/7 medical support for critical safety issues.
Qualifications:
- Medical degree (MBBS/MD) from an accredited institution.
- 3+ years of clinical practice + 2+ years in pharmacovigilance/pharma.
- Expertise in ICH-GCP, GVP, and safety databases.
- Strong medical writing skills for aggregate reports.
- Valid medical license (preferred).
3. Senior Medical Safety Advisor – Bangalore
Job Type: Full-Time
End Date: 31st December 2025
Location: Bengaluru, Karnataka
Job Description:
This role involves medical safety assessments, signal detection, and regulatory compliance for clinical trials and post-marketing surveillance. The advisor will collaborate with global teams to ensure patient safety and regulatory adherence.
Key Responsibilities:
- Conduct medical review of SAEs, SUSARs, and ADRs.
- Support DSURs, PBRERs, and risk management plans.
- Lead safety training and audit preparations.
- Act as EU QPPV backup (if required).
Qualifications:
- Medical degree (MBBS/MD) + 3+ years clinical experience.
- 2+ years in pharmacovigilance/drug safety.
- Knowledge of MedDRA coding, E2B, and safety databases.
- Strong analytical and communication skills.
How to Apply?
Application Link For Regulatory Affairs Specialist
