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Drug Safety Physician

ICON
2-3 years
Not Disclosed
Chennai, Trivandrum, India
15 Sept. 10, 2026
Job Description
Job Type: Full Time, Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding

Drug Safety Physician

Company: ICON
Job Requisition ID: JR152349
Employment Type: Full-time
Work Mode: Office With Flex
Locations: Chennai, India; Trivandrum, India
Posted: 15 days ago

About ICON

ICON is a global healthcare intelligence and clinical research organisation focused on bringing new medicines and treatments to patients faster.

The company operates with four core values:

Role Overview

The Drug Safety Physician provides medical and safety support to ICON project teams, ensuring projects are conducted according to high ethical and medical standards, GCP, good pharmacovigilance practices, and applicable regulatory requirements.

Key Responsibilities

Required Qualifications & Experience

Key Skills

Benefits

ICON offers a comprehensive rewards and benefits package, which may include:

Benefits may vary by role and location.

Equal Opportunity

ICON is an equal opportunity and inclusive employer committed to providing a workplace free from discrimination and harassment.

Reasonable accommodations are available during the recruitment process for candidates who require them.

Important Eligibility Note

This is a physician-specific Drug Safety role. The key mandatory requirement is a qualified and licensed physician with 2–3 years of hospital-based diagnosis and treatment experience.

Therefore, B.Pharm/M.Pharm candidates without a medical degree and physician license would generally not meet the stated eligibility criteria, even if they have pharmacovigilance experience.

 

Accountability & Delivery

Collaboration

Partnership

Integrity

Review MedDRA coding and assess adverse events and adverse drug reactions.

Assess seriousness, expectedness, listedness, and relatedness of AEs/ADRs.

Review aggregate safety reports, including patient profiles, line listings, IND annual reports, Annual Safety Reports, and PSURs.

Assess safety issues arising from clinical trials and post-marketing activities.

Escalate significant safety issues and support resolution discussions with clients.

Provide support and training on regulatory requirements for expedited and periodic safety reporting.

Support reporting requirements for clinical trials, post-authorisation studies, spontaneous reports, and literature.

Review and provide input on Project Specific Procedures.

Participate in project-related meetings and client communications.

Support code-break activities.

Review and provide input on Product Information, Company Core Data Sheets, Core Safety Information, and other product-related information.

Provide pharmacovigilance consultancy regarding expedited and periodic reporting requirements.

Provide guidance to Medical and Safety Services teams on adverse-event regulatory reporting.

Perform other responsibilities as assigned.

Qualified and licensed physician.

2–3 years of patient diagnosis and treatment experience in a hospital-based setting.

Prior experience in clinical research or pharmacovigilance is an added advantage.

Pharmacovigilance and drug safety

Medical review of adverse events

MedDRA coding

Seriousness and relatedness assessment

Expectedness and listedness assessment

Clinical trial safety

Post-marketing safety surveillance

Expedited and periodic safety reporting

Aggregate safety report review

Product Information and Core Safety Information

GCP and pharmacovigilance regulations

Regulatory reporting requirements

Client and stakeholder communication

Competitive salary

Performance-related incentives

Health and wellbeing programmes

Medical benefits

Retirement and pension plans

Life assurance

Employee assistance programmes

Learning and development opportunities

Structured training and career pathways