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Senior Medical Safety Advisor

Iqvia
IQVIA
3+ years
Not Disclosed
Bangalore, Thane, India
1 May 6, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, 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

Senior Medical Safety Advisor

Location: Bangalore, India / Thane, Maharashtra, India
Job Type: Full-Time
Experience Required: Minimum 3+ Years of Clinical Practice Experience | 2+ Years of Pharma or Pharmacovigilance Experience Preferred
Application Deadline: May 29, 2026
Industry: Pharmacovigilance / Clinical Research / Pharmaceutical Safety


Job Overview

We are seeking a highly experienced and medically qualified Senior Medical Safety Advisor to support global pharmacovigilance and drug safety activities across clinical trials and post-marketing programs. The selected candidate will provide medical expertise in evaluating safety data, assessing adverse events, reviewing aggregate safety reports, and ensuring compliance with global pharmacovigilance standards.

This role is ideal for medical professionals with strong expertise in clinical safety, pharmacovigilance, adverse event assessment, medical review, and regulatory safety reporting within pharmaceutical or CRO environments.


Key Responsibilities

Medical Safety Review & Pharmacovigilance

  • Perform medical review and assessment of:
    • Adverse Events (AEs)
    • Serious Adverse Events (SAEs)
    • Adverse Drug Reactions (ADRs)
    • Safety narratives
    • Causality assessments
    • Expectedness evaluations
  • Review:
    • Coding accuracy
    • Medical histories
    • Concomitant medications
    • Clinical safety data listings
  • Ensure medically accurate evaluation of safety information within the context of product safety profiles and therapeutic areas.

Aggregate Safety Reporting

  • Support preparation and review of:
    • DSURs (Development Safety Update Reports)
    • RMPs (Risk Management Plans)
    • PBRERs
    • Regulatory safety reports
    • Aggregate safety assessments
  • Conduct literature reviews and evaluate observational study data for ongoing product safety surveillance.
  • Participate in signal detection and safety surveillance activities for assigned products.

Clinical Safety & Protocol Review

  • Perform medical safety review of:
    • Clinical trial protocols
    • Investigative Brochures (IB)
    • Case Report Forms (CRFs)
    • Medical Monitoring Plans
    • Project Safety Plans
  • Ensure proper safety data capture and protocol compliance within clinical research programs.

Leadership & Team Support

  • Serve as:
    • Lead Safety Physician
    • Medical Safety Advisor
    • Safety team escalation support
  • Provide guidance and mentoring to pharmacovigilance and clinical safety team members.
  • Support:
    • Product transitions
    • Audit preparation
    • Training activities
    • Knowledge-sharing initiatives
  • Participate in client meetings and present safety review findings when required.

Regulatory Compliance & Operational Oversight

  • Ensure delivery of safety activities within:
    • Regulatory timelines
    • Compliance requirements
    • Quality standards
  • Maintain awareness of:
    • Global pharmacovigilance regulations
    • Industry safety developments
    • GCP/ICH guidelines
  • Provide medical escalation support for:
    • Medical information projects
    • EU Qualified Person for Pharmacovigilance (QPPV) support activities
    • 24-hour medical safety support where required.

Required Qualifications

Educational Qualifications

Mandatory Qualification:

  • Medical Degree from an accredited and internationally recognized medical school:
    • MBBS
    • MD
    • Equivalent Medical Qualification

Preferred Qualifications

  • Valid medical license preferred.
  • Additional expertise or certifications in:
    • Pharmacovigilance
    • Clinical Research
    • Drug Safety
    • Regulatory Affairs
    • Clinical Development