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Sr Medical Safety Advisor

2-3 years
Not Disclosed
10 July 16, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

Location: Bengaluru, India
Work Mode: Hybrid
Job Type: Full-time
Experience Level: 3+ years in clinical practice, 2+ years in pharma preferred
Salary Range: Not specified


Job Summary

IQVIA is seeking a highly skilled Senior Medical Safety Advisor to join their pharmacovigilance team in Bengaluru. This role offers an exciting opportunity to provide medical expertise in reviewing safety data, leading aggregate report development, and overseeing post-marketing surveillance. As a senior technical leader, you will drive signal detection, regulatory compliance, and cross-functional training initiatives in a global drug safety environment.


Key Responsibilities

  • Conduct medical review of trial-related and post-marketing AEs/ADRs including narratives and causality assessments.

  • Medically review Analyses of Similar Events (AOSE) and validate case coding (MedDRA, WHO-DD).

  • Perform medical review of study documents such as protocols, CRFs, and IBs.

  • Lead or support the creation of aggregate safety documents like DSURs, RMPs, and PBRERs.

  • Maintain product watch lists, labeling documents, RSI updates, and expectedness logs.

  • Represent medical safety in client meetings, internal reviews, and regulatory discussions.

  • Train safety team members, lead knowledge exchange, and contribute to audit readiness.

  • Participate in signal detection strategy meetings and risk evaluation planning.

  • Offer 24/7 medical safety support as required for assigned projects.

  • Serve as Lead Safety Physician or medical escalation point on pharmacovigilance projects.


Required Skills & Qualifications

  • Medical degree from an accredited institution (MBBS or equivalent) – Required

  • Minimum 3 years of clinical practice experience post-graduation – Required

  • At least 2 years in pharmacovigilance or pharma industry – Preferred

  • Strong knowledge of ICH-GCP, global PV regulations, and clinical research standards

  • Familiarity with MedDRA, ICSR processing, and safety databases (e.g., Argus, ArisG)

  • Experience in authoring aggregate safety reports (DSUR, PBRER, RMP)

  • Excellent verbal and written communication and presentation skills

  • Ability to work cross-functionally and manage competing timelines

  • Valid medical license preferred


Perks & Benefits

  • Opportunity to work with a global leader in clinical safety and regulatory science

  • Exposure to cutting-edge pharmacovigilance tools and global processes

  • Collaborative and innovation-driven environment

  • Professional development and leadership opportunities

  • Hybrid work flexibility and international project exposure


Company Overview

IQVIA is a global leader in advanced analytics, technology solutions, and clinical research services, supporting pharmaceutical and life sciences companies in bringing innovative treatments to market faster and more efficiently. IQVIA delivers intelligent healthcare solutions that improve outcomes and population health worldwide.


Work Mode

Hybrid – Based in Bengaluru, with flexibility to support global time zones and remote work options.


Call to Action

If you're an experienced medical professional passionate about pharmacovigilance and ready to take on a leadership role in drug safety, apply now to join IQVIA’s expert global team.