IQVIA, a global leader in clinical research and healthcare intelligence, is hiring a Senior Medical Safety Advisor in Pune, India. This role offers a unique opportunity for experienced medical professionals to advance their career in pharmacovigilance, drug safety, and clinical research oversight. If you have a strong medical background and expertise in regulatory compliance, this is your chance to join a world-class team.
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Key Responsibilities
As a Sr. Medical Safety Advisor, you will:
- Conduct medical review of adverse events (AEs) and adverse drug reactions (ADRs) in both clinical trials and post-marketing settings.
- Compose, edit, and review Analyses of Similar Events (AOSE) for expedited cases.
- Review and medically validate coding of AEs, SAEs, past medical history, and concomitant medications.
- Provide guidance to pharmacovigilance teams and act as a safety consultant.
- Perform aggregate safety reviews including DSUR, PBRER, RMP, and literature reports.
- Lead training, audits, safety planning, and product safety transitions.
- Support regulatory compliance and signal detection strategies.
- Act as Lead Safety Physician or provide backup medical safety support for projects.
Qualifications
- Medical degree (MBBS, MD, or equivalent) from an accredited institution.
- Minimum 3 years of clinical practice experience post-graduation (residency training acceptable).
- At least 2 years of pharmaceutical or clinical research experience preferred.
- Strong knowledge of ICH-GCP, global PV regulations, ICSR & aggregate safety reporting.
- Skilled in safety databases, Microsoft Office, and regulatory documentation.
- Valid medical license preferred.
- Excellent communication and leadership abilities.
Why Join IQVIA?
- Be part of a global leader in life sciences and healthcare research.
- Opportunity to work with cutting-edge pharmacovigilance and safety systems.
- Collaborative work culture with exposure to international projects.
- Competitive salary with growth opportunities.
How to Apply
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