Senior Medical Safety Advisor – Pharmacovigilance
Location: Bengaluru, India (Home-based)
Job Type: Full-Time
Work Mode: Remote
Job Summary:
IQVIA is hiring a Senior Medical Safety Advisor to join its global pharmacovigilance division. This fully remote role is ideal for experienced medical professionals with strong backgrounds in drug safety, clinical data review, and regulatory compliance. You’ll play a pivotal role in analyzing adverse event data, managing signal detection, contributing to aggregate reports, and supporting regulatory filings to ensure global drug safety and compliance.
Key Responsibilities:
Conduct medical review of adverse events (AEs), SAEs, and ADRs, assessing seriousness, causality, coding, and narrative quality.
Author and review Analyses of Similar Events (AOSE) per global regulatory standards.
Review and provide expert input on safety-related sections of protocols, IBs, and CRFs.
Lead review of aggregate safety data: DSUR, RMP, PBRER, literature surveillance, and ad hoc reports.
Serve as internal consultant on safety case assessments and provide escalation support.
Manage surveillance activities for assigned products including RSI updates and signal detection strategies.
Attend client meetings and represent medical safety reviews and recommendations.
Contribute to SOP adherence, safety process optimization, and audit preparedness.
Mentor team members and lead training initiatives on pharmacovigilance topics.
Support QPPV projects and provide 24-hour medical support as required.
Required Skills & Qualifications:
Medical degree from a recognized and accredited international medical school (mandatory).
Minimum 3 years clinical practice post-degree (residency/graduate medical training acceptable).
At least 2 years' experience in pharmacovigilance or pharmaceutical industry preferred.
In-depth knowledge of ICH-GCP, global PV regulations, and aggregate report writing.
Strong experience in using safety databases and reviewing medical coding.
Proficiency in Microsoft Word, Excel, PowerPoint, and digital PV tools.
Excellent communication and presentation skills.
Ability to manage global projects, timelines, and cross-functional collaboration.
Valid medical license preferred.
Perks & Benefits:
100% remote work flexibility from anywhere in India.
Involvement in global drug safety operations and multi-national clinical programs.
Training, mentorship, and career development opportunities.
Competitive compensation package.
Exposure to cutting-edge pharmacovigilance tools and systems.
About the Company:
IQVIA is a global leader in clinical research, healthcare analytics, and life sciences consulting, empowering innovation through advanced data science and medical expertise. IQVIA partners with top pharma and biotech companies to enhance patient outcomes and accelerate regulatory success worldwide.
Work Mode:
Remote – India
Call-to-Action:
Are you ready to lead global pharmacovigilance from the frontlines of innovation? Apply now and join IQVIA’s expert safety team to help ensure the safety of therapies that impact millions of lives.
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