Senior Medical Safety Advisor
📍 Location: Bengaluru, India (Home-based)
💼 Job ID: R1471135
🕒 Type: Full-time
🌍 Additional Location: Bengaluru, India
About the Role
IQVIA is seeking a Senior Medical Safety Advisor to provide medical and scientific expertise in the evaluation of safety data from clinical trials, post-marketing surveillance, literature, and other sources.
This role focuses on interpreting adverse event data, ensuring regulatory compliance, and maintaining safety oversight for assigned products. As a senior member, you’ll act as a technical leader, guiding pharmacovigilance teams, supporting safety evaluations, and collaborating across functions to manage product safety profiles.
Key Responsibilities
1. Adverse Event & Case Review
Conduct medical review of clinical and post-marketing Adverse Events (AEs) and Adverse Drug Reactions (ADRs), including:
narrative evaluation, coding, expectedness, seriousness, causality, and company summaries.
Prepare, edit, and review Analyses of Similar Events (AOSE) for expedited cases per regulatory requirements.
Review coding for AEs, SAEs, SADRs, past medical history, and concomitant medications to ensure medical accuracy.
2. Clinical Safety Oversight
Provide medical safety review of protocols, Investigator Brochures (IBs), and Case Report Forms (CRFs) for appropriate safety content.
Conduct aggregate safety reviews (e.g., DSURs, RMPs, PBRERs, and ad-hoc regulatory reports).
Maintain ongoing surveillance and evaluation of assigned products’ safety profiles using clinical, post-marketing, and literature data.
Support signal detection and risk management strategy meetings.
3. Leadership & Team Support
Act as a Lead Safety Physician or provide backup medical support on assigned projects.
Offer guidance and mentorship to pharmacovigilance case processing teams.
Drive training initiatives, audit readiness, and knowledge-sharing sessions across the safety function.
Ensure team compliance, productivity, and quality in service delivery within regulatory timelines.
Oversee maintenance of watch lists, expectedness lists, labeling lists, and RSI updates for assigned products.
4. Strategic & Operational Contributions
Review and sign off on Project Safety Plans and Medical Monitoring Plans as per contractual scope.
Attend and represent medical safety in project meetings, client calls, and cross-functional discussions.
Provide medical escalation support for Medical Information and EU QPPV projects as required.
Offer 24-hour on-call medical support for assigned studies and pharmacovigilance activities.
5. Continuous Development
Stay current with medical, safety, and regulatory industry updates.
Actively participate in signal detection activities and strategic safety initiatives.
Qualifications
Education
Required: Medical Degree (M.D. or equivalent) from an accredited and internationally recognized institution.
Preferred: Valid medical license or equivalent from the country/region of residence.
Experience
Minimum 3 years of clinical practice after earning a medical degree (graduate or residency training accepted).
Minimum 2 years of pharmaceutical industry experience preferred, ideally in pharmacovigilance or clinical safety.
Knowledge & Skills
Strong foundation in medicine and pharmacovigilance (ICSR and aggregate report expertise).
In-depth knowledge of global clinical research regulations, including ICH and GCP guidelines.
Proficiency in safety databases and Microsoft Office Suite (Word, Excel, PowerPoint).
Solid understanding of departmental SOPs and safety reporting procedures.
Excellent written and verbal communication skills.
Ability to prioritize, lead, and collaborate effectively across teams and clients.
About IQVIA
IQVIA is a global leader in clinical research, commercial insights, and healthcare intelligence, driving innovation across the life sciences industry.
We connect data, technology, and expertise to accelerate medical breakthroughs and improve patient outcomes worldwide.
🌐 Learn more: https://jobs.iqvia.com
Apply Now
If you’re a medically trained professional with proven pharmacovigilance expertise and a passion for patient safety —
👉 Apply now to join IQVIA as a Senior Medical Safety Advisor and make an impact on global healthcare.
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