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Senior Medical Safety Advisor

Iqvia
IQVIA
5+ years
preferred by company
Remote, India, Thane, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: MBBS/MD/ BAMS/ BDS/ MDS Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment

Senior Medical Safety Advisor – Remote Pharmacovigilance Physician Jobs in Thane | IQVIA

Location: Thane, India
Company: IQVIA
Job Type: Full-Time
Work Mode: Home-Based / Remote
Department: Pharmacovigilance / Medical Safety / Drug Safety / Clinical Safety
Experience Required: Minimum 5+ years total relevant experience (3+ years clinical medicine + pharma / pharmacovigilance experience preferred)
Job Reference ID: R1524203


About IQVIA

IQVIA is a globally recognized leader in clinical research services, healthcare intelligence, pharmacovigilance, life sciences consulting, and medical safety operations. The company partners with pharmaceutical, biotechnology, and healthcare organizations to accelerate clinical development, improve patient safety, and optimize healthcare outcomes worldwide.

This opportunity is ideal for experienced medical professionals seeking senior careers in medical safety, pharmacovigilance, drug safety physician roles, aggregate safety reporting, signal detection, and global clinical safety leadership.


Job Overview

IQVIA is hiring a Senior Medical Safety Advisor for a remote home-based opportunity in Thane, India. This physician-level leadership role is ideal for medical professionals with expertise in pharmacovigilance, clinical safety review, adverse event evaluation, aggregate safety reporting, signal detection, medical monitoring, and regulatory safety compliance.

The selected candidate will provide medical oversight across clinical trials and post-marketing safety programs, supporting AE/SAE review, safety case assessment, aggregate reporting, benefit-risk evaluation, product safety surveillance, safety governance, and global pharmacovigilance leadership.

This is an excellent opportunity for physicians looking to build strategic careers in medical safety, drug safety leadership, and pharmacovigilance advisory roles within a leading global healthcare organization.


Key Responsibilities

Medical Safety Review & Pharmacovigilance Leadership

  • Perform physician-led review of:
    • Trial-related Adverse Events (AEs)
    • Serious Adverse Events (SAEs)
    • Post-marketing Adverse Drug Reactions (ADRs)
    • Safety narratives
    • Medical queries
    • Expectedness assessments
    • Seriousness evaluations
    • Causality assessments
    • Company safety summaries
  • Ensure scientific and regulatory quality across pharmacovigilance deliverables.

Aggregate Safety Reporting & Benefit-Risk Evaluation

  • Prepare and medically review:
    • Development Safety Update Reports (DSUR)
    • Risk Management Plans (RMP)
    • Periodic Benefit-Risk Evaluation Reports (PBRER)
    • Ad-hoc regulatory safety reports
    • Aggregate safety assessments
  • Conduct medical review of:
    • Clinical safety data
    • Post-marketing surveillance data
    • Literature safety findings
    • Observational study safety information

Medical Case Assessment & Coding Oversight

  • Compose and medically review Analysis of Similar Events (AOSE) for expedited reporting cases.
  • Review coding for:
    • AEs
    • SAEs
    • SADRs
    • Medical history
    • Concomitant medications
    • Safety listings
  • Serve as internal medical consultant for pharmacovigilance case processing teams.

Clinical Trial Safety & Medical Monitoring

  • Perform medical review of:
    • Clinical study protocols
    • Investigative Brochures
    • Case Report Forms (CRFs)
    • Project Safety Plans
    • Medical Monitoring Plans
  • Ensure appropriate clinical safety data capture and protocol-level safety compliance.

Signal Detection & Product Safety Surveillance

  • Support:
    • Signal detection strategy meetings
    • Product watch list management
    • Expectedness list maintenance
    • RSI / labeling updates
    • Safety surveillance oversight
  • Maintain awareness of emerging global medical safety regulations.

Leadership, Training & Operational Excellence

  • Act as:
    • Lead Safety Physician
    • Backup medical safety expert
    • Safety escalation contact
  • Lead:
    • Product transitions
    • Team mentoring
    • Training initiatives
    • Audit readiness preparation
    • Knowledge-sharing programs
  • Ensure productivity, quality, compliance, and timeline adherence.

Client & Cross-Functional Collaboration

  • Attend:
    • Medical safety meetings
    • Project governance meetings
    • Client review discussions
    • Safety oversight forums
  • Present clinical safety findings and recommendations to internal and external stakeholders.
  • Provide medical escalation support for pharmacovigilance and EU QPPV-related programs where applicable.

Operational Support

  • Provide 24-hour medical support where project assignments require continuous physician oversight.

Required Qualifications

Educational Qualification (Mandatory)

  • Medical degree from an accredited and internationally recognized medical school

Eligible qualifications include:

  • MBBS
  • MD
  • Equivalent recognized medical qualification

Required Experience

  • Minimum 3+ years of clinical medicine practice
  • Pharma / CRO / pharmacovigilance experience preferred
  • Equivalent relevant experience in:
    • Clinical research
    • Drug safety
    • Pharmacovigilance
    • Contract research
    • Medical safety