IQVIA is seeking a highly qualified Senior Medical Safety Advisor to provide medical expertise in pharmacovigilance and drug safety. The role involves evaluating safety data from clinical trials and post-marketing reports, ensuring compliance with regulatory requirements, and contributing to risk management strategies.
As a Senior Medical Safety Advisor, you will:
- Conduct medical reviews of adverse events (AEs) and adverse drug reactions (ADRs), ensuring accuracy in causality, seriousness, and expectedness assessments.
- Prepare and review Analyses of Similar Events (AOSE) for expedited regulatory reporting.
- Provide medical oversight for coding of AEs, SAEs, medical history, and concomitant medications.
- Review protocols, Investigator Brochures, and Case Report Forms (CRFs) for safety data accuracy.
- Contribute to aggregate safety reports such as DSURs, PBRERs, RMPs, and ad-hoc regulatory documents.
- Lead signal detection activities and participate in safety surveillance initiatives.
- Support EU QPPV (Qualified Person for Pharmacovigilance) and medical information teams.
- Ensure compliance with GCP, ICH guidelines, and global pharmacovigilance regulations.
Key Responsibilities
✔ Perform medical safety reviews of ICSRs (Individual Case Safety Reports) and aggregate reports.
✔ Provide therapeutic area expertise for safety assessments and risk management.
✔ Train and mentor junior pharmacovigilance professionals.
✔ Participate in audits, inspections, and process improvement initiatives.
✔ Maintain up-to-date knowledge of pharmacovigilance regulations and industry trends.
Qualifications & Experience
Essential Requirements:
- Medical Degree (MBBS/MD) from an accredited institution.
- Minimum 3 years of clinical practice experience post-medical degree (residency/internship included).
- 2+ years of pharmaceutical industry experience (preferred).
- Strong knowledge of GCP, ICH guidelines, and global safety regulations.
- Experience with pharmacovigilance databases (e.g., ARGUS, ARISg, Veeva).
- Excellent medical writing and communication skills.
Preferred Skills:
- Valid medical license (preferred).
- Experience in signal detection, risk management plans (RMPs), and aggregate reporting.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
About IQVIA
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. With a focus on improving patient outcomes, IQVIA delivers intelligent insights that accelerate drug development and commercialization.
🔹 Why Join IQVIA?
- Work with a globally recognized leader in healthcare intelligence.
- Opportunities for career growth and skill development.
- Collaborative and innovative work environment.
How to Apply
