Instagram
youtube
Facebook

Senior Medical Safety Advisor

2 years
Not Disclosed
10 Sept. 8, 2025
Job Description
Job Type: Full Time Education: MD, MBBS Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🏷️ Job Title:

Senior Medical Safety Advisor

Job ID: R1497941
Location: Bengaluru, India (Hybrid)
Employment Type: Full-time
Job Available in Additional Locations

Apply Now | Save Job | Share via: Email | LinkedIn | Facebook | X


🧭 Job Overview

This role provides medical expertise in evaluating safety data from diverse sources within the pharmacovigilance process. The Senior Medical Safety Advisor assesses the medical and scientific relevance of serious adverse event (SAE) reports, placing them in the context of the product’s safety profile and therapeutic area. This role also serves as a senior technical leader, contributing to cross-functional activities, aggregate report preparation, and ongoing safety surveillance for selected products.


🔍 Key Responsibilities

🔎 Medical & Scientific Evaluation

  • Perform medical review and clarification of:

    • Trial-related Adverse Events (AEs)

    • Post-marketing Adverse Drug Reactions (ADRs)

  • Evaluate:

    • Narrative content

    • Clinical queries

    • Medical coding

    • Expectedness, seriousness, and causality

    • Company’s medical summaries

🧪 Safety Surveillance & Reporting

  • Participate in aggregate safety data reviews and signal detection activities.

  • Support preparation and medical review of:

    • Aggregate safety reports

    • Periodic Safety Update Reports (PSURs)

    • Development Safety Update Reports (DSURs)

    • Other regulatory submissions

  • Collaborate with Post-Marketing Safety Experts and the Safety Surveillance Group to ensure ongoing product safety surveillance.

🧠 Subject Matter Expertise

  • Serve as a senior medical and scientific expert within pharmacovigilance.

  • Provide input into product safety strategy and risk management plans.

  • Interpret complex clinical data and determine potential safety implications.

🤝 Cross-functional Collaboration

  • Work closely with:

    • Regulatory affairs

    • Clinical development teams

    • Safety scientists

    • Data management

    • Signal detection and risk management teams

  • Provide support during inspections, audits, and regulatory authority interactions.


📚 Qualifications

  • Education:
    MD, MBBS, or equivalent degree in medicine required. Specialization in pharmacovigilance, clinical pharmacology, or a relevant therapeutic area is a plus.

  • Experience:

    • Significant experience in pharmacovigilance, clinical research, or drug safety.

    • Experience in medical evaluation of AEs/ADRs and aggregate reporting.

    • Strong understanding of global regulatory requirements (e.g., ICH, FDA, EMA).


🧠 Key Skills & Competencies

  • Strong clinical judgment and ability to evaluate medical safety information.

  • Proficiency in narrative writing, case evaluation, and risk assessment.

  • Knowledge of drug development lifecycle and pharmacovigilance operations.

  • Strong written and verbal communication skills.

  • Attention to detail, analytical thinking, and problem-solving abilities.

  • Ability to work independently and in a cross-functional global environment.

  • Familiarity with medical coding systems (MedDRA, WHO-ART) and safety databases.


🏢 About IQVIA

IQVIA is a global leader in clinical research, healthcare analytics, and real-world evidence generation. Through advanced data, technology, and insights, we help bring innovative therapies to market and improve health outcomes worldwide.

🔗 Learn more: https://jobs.iqvia.com


📩 Ready to Apply?

Click here to Apply Now
Save Job | Share This Job