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Dir, Medical Safety

IQVIA
5+ years
INR 25-30 LPA
Kolkata, India
10 June 16, 2026
Job Description
Job Type: Full Time, Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Communication Skills, CPC Certified, CPT, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, GCP guidelines, HCPCS Level II, ICD-10-CM, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICD-10-PCS, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding

Job Title

Medical Safety Physician / Medical Monitor / Pharmaceutical Physician

Experience Required

Mandatory Experience

  • 5+ Years Clinical Practice Experience after obtaining a medical degree

OR

  • 3 Years Clinical Practice Experience

  • Plus 2 Years as a Pharmaceutical Physician in any relevant industry role

Industry Experience

  • 5+ Years in:

    • Medical Safety

    • Medical Monitoring

    • Pharmacovigilance

    • Clinical Development

    • Drug Safety

    • Pharmaceutical Industry


Education

Mandatory

  • Medical Degree (MBBS/MD or equivalent)

  • Degree must be from an accredited and internationally recognized medical school

Licensing Requirements

  • Valid Medical License (or equivalent)

  • License must be valid in the country/region where the physician resides and works


Job Overview

This role involves providing expert medical oversight for clinical trials, patient safety monitoring, medical review activities, and regulatory compliance.

The physician will collaborate with:

  • Clinical Operations Teams

  • Sponsors

  • Regulatory Authorities

  • Pharmacovigilance Teams

  • Investigators

  • CRO Project Teams

The primary focus is ensuring:

  • Patient safety

  • Medical oversight

  • Regulatory compliance

  • Scientific integrity of clinical studies


Key Responsibilities

Medical Safety Oversight

  • Review and assess safety data from clinical studies.

  • Evaluate:

    • Serious Adverse Events (SAEs)

    • Adverse Events (AEs)

    • Safety Signals

    • Laboratory Abnormalities

  • Ensure participant safety throughout study conduct.


Medical Monitoring

  • Provide ongoing medical monitoring of clinical trials.

  • Review patient profiles and clinical data.

  • Identify medical inconsistencies and protocol deviations.

  • Support risk assessment activities.


Regulatory Compliance

  • Ensure compliance with:

    • ICH-GCP Guidelines

    • Global Safety Regulations

    • Local Regulatory Requirements

    • Clinical Trial Regulations

  • Support inspection readiness and audit activities.


Clinical Trial Support

  • Provide medical consultation to study teams.

  • Assist investigators with medical questions.

  • Review eligibility criteria and protocol-related medical issues.


Leadership & Stakeholder Management

  • Lead medical discussions with:

    • Sponsors

    • Clients

    • Internal teams

    • Investigators

  • Build strong relationships with stakeholders.

  • Provide medical guidance across multiple projects.


Project & Financial Management

  • Manage priorities and project timelines.

  • Support resource planning.

  • Contribute to project budgeting and financial oversight where required.


Medical Expertise & Consultation

  • Serve as Subject Matter Expert (SME).

  • Provide scientific and therapeutic area guidance.

  • Support benefit-risk evaluations.


Required Skills & Knowledge

Medical & Scientific Knowledge

Strong Understanding Of:

  • Clinical Medicine

  • Pharmacology

  • Pathophysiology

  • Drug Safety

  • Clinical Development

  • Risk-Benefit Assessment


Clinical Research Knowledge

Strong Understanding Of:

  • Clinical Trial Processes

  • ICH-GCP Guidelines

  • Regulatory Requirements

  • Medical Monitoring

  • Pharmacovigilance


Leadership Skills

  • Team Leadership

  • Stakeholder Management

  • Decision Making

  • Strategic Thinking

  • Conflict Resolution


Project Management Skills

  • Project Planning

  • Financial Management

  • Risk Management

  • Timeline Management

  • Resource Allocation


Soft Skills

  • Excellent Communication

  • Problem Solving

  • Client Relationship Management

  • Collaboration

  • Adaptability

  • Organizational Skills


Physical & Work Environment Requirements

Work Requirements

  • Extensive use of:

    • Email

    • Telephone

    • Virtual Meetings

    • Client Interactions

Physical Requirements

  • Long periods of sitting

  • Extensive keyboard usage

  • Frequent document review

Travel Requirement

  • Approximately 10% Travel

  • Based on client or project needs


Preferred Candidate Profile

Must Have

✅ Medical Degree (MBBS/MD)

✅ Valid Medical License

✅ Clinical Practice Experience

✅ Medical Safety or Medical Monitoring Experience

✅ Knowledge of Clinical Research Regulations


Highly Preferred

✅ Pharmacovigilance Experience

✅ CRO Experience

✅ Clinical Development Experience

✅ Global Clinical Trial Exposure

✅ Leadership Experience