Senior Physician, Patient Safety

Parexel

2+ years

Not Disclosed

Remote, India, India

Openings: 10 May 26, 2026

Job Description

Job Type: Full Time Hybrid Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Physician – Patient Safety

Company: Parexel
Job ID: R0000041129
Location: Remote (India)
Category: Medical Sciences

Job Summary

The Senior Physician – Patient Safety is responsible for providing medical and scientific expertise in pharmacovigilance, medical monitoring, signal detection, aggregate reporting, and risk management activities. The role supports global drug safety operations through medical review, regulatory compliance, safety assessments, client interaction, mentoring, and cross-functional collaboration.

Key Responsibilities

1. General Pharmacovigilance & Safety Oversight

Maintain strong knowledge of:
- Adverse event and safety profiles of assigned products
- Labeling documents
- Data handling conventions
- Client guidelines and SOPs
- Global drug safety regulations
Ensure compliance with:
- Internal timelines
- Regulatory reporting requirements
Communicate safety review issues with:
- Line Managers
- Project Leads
- Clients
- Internal stakeholders
Participate in:
- Cross-functional meetings
- Client meetings
- Audit and inspection support
- Bid defense meetings
Act as:
- Subject Matter Expert (SME)
- Pharmacovigilance representative
- Safety scientist
Support:
- Process improvements
- KPI management
- Team coordination
Mentor Patient Safety Physicians and junior team members.

2. Case Report Medical Review

Perform medical review of:
- Clinical trial cases
- Literature cases
- Combination product cases (drug-device)
- Complex safety cases requiring expert judgment
Responsibilities include:
- Writing MAH/PV comments
- Assessing company causality
- Evaluating seriousness and expectedness
- Reviewing narrative medical coherence
- Verifying MedDRA coding
- Reviewing adverse event selection from source documents
Raise follow-up queries to:
- Reporters
- Healthcare professionals (HCPs)
Coordinate with:
- Therapeutic teams
- Legal teams
- Clients
Guide junior physicians on case assessment methodologies.

3. Aggregate Safety Reports & Periodic Reporting

Review and/or author aggregate safety reports, including:
- PBRERs
- PSURs
- DSURs
- Signal Evaluation Reports (SERs)
- Clinical Overviews (COs)
- Addendum to Clinical Overviews (ACOs)
- Health Hazard Evaluation Reports (HHEs)
- Health Authority response documents
Provide:
- Medical review for consistency and scientific accuracy
- Clinical expert statements
- Regulatory safety inputs
Review work completed by junior team members.

4. Medical Monitoring Activities

Provide medical and scientific support to:
- Parexel staff
- Investigators
- Study coordinators
Review and sign off:
- Adverse event reports
- Data management listings
- Technical medical documents
- Coding of adverse events and medications
- Patient profile reports
Assess:
- Clinical significance of safety trends
- Drug-event relationships
- Severity and seriousness of events
Support preparation of:
- Clinical protocols
- Study reports
- Journal articles
- Integrated clinical/statistical summaries
Participate in:
- Investigator meetings
- Regulatory meetings
- Therapeutic area training sessions

5. Literature Review & Safety Assessment

Review scientific literature for:
- Product safety evaluation
- Potential safety concerns
- Epidemiology background research
Perform:
- Literature triage
- Summarization
- MAH comment preparation
Support:
- Aggregate reporting
- Signal management activities

6. Clinical Study Report (CSR) Narratives

Perform medical review of CSR narratives according to:
- Client guidelines
- SOPs
Provide medical guidance to:
- Pharmacovigilance teams
- Study teams

7. Signal Detection & Signal Management

Perform:
- Signal detection
- Signal validation
- Medical assessment of safety alerts
Author/review:
- Signal Evaluation Reports (SERs)
- Health Authority responses
- Safety documents
Conduct:
- Case analysis
- Literature review
- Medical accuracy checks
Manage signals using:
- Signal tracking systems
- Signal management tools
Contribute to Safety Management Team (SMT) meetings through:
- Data analysis
- Presentations
- Meeting facilitation
- Documentation
Mentor junior staff on signal detection methodologies.

8. Brand Safety Physician Responsibilities

Support pharmacovigilance and risk management planning for designated products.
Contribute to:
- Safety surveillance strategies
- Risk Management Plans (RMPs)
- Core safety documents and labeling
Prepare/review:
- PBRERs/PSURs
- DSURs
- HHEs
- Renewal safety reports
- SERs
Coordinate safety activities with:
- Drug Safety Units
- Internal teams
- External partners
Contribute to:
- Regulatory submissions
- INDs
- NDAs
- Marketing authorization applications
- Variations and renewals
Participate in:
- Safety Monitoring Boards
- Independent monitoring committees

9. Therapeutic Area Expertise

Serve as SME within assigned therapeutic areas.
Collaborate with Therapeutic Area Leads to:
- Develop strategic plans
- Improve therapeutic expertise
- Enhance pharmacovigilance processes
Support:
- Scientific presentations
- Publications
- Thought leadership activities
Mentor junior physicians and contribute to innovation initiatives.

Required Skills

Strong clinical medicine background
Expertise in pharmacovigilance and drug development processes
Ability to assess clinical relevance of medical data
Strong analytical and scientific reasoning skills
Excellent verbal and written communication abilities
Good presentation and interpersonal skills
Client-focused approach
Strong teamwork and collaboration mindset
Ability to manage multiple complex tasks efficiently
Experience mentoring junior staff
Flexibility and adaptability in matrix environments
Knowledge of:
- ICH GCP
- GVP
- International drug safety regulations
Proficiency in:
- Microsoft Office
- Web-based applications
- Windows operating systems

Preferred Experience

Experience in:
- Pharmacovigilance
- Drug safety
- Medical monitoring
- Clinical practice
Good understanding of:
- Medical terminology
- Safety reporting
- Clinical data interpretation

Educational Qualifications

Required qualifications:

MBBS
MD (preferred)
Medical degree from a recognized medical school

Additional requirement:

Completion of basic clinical training such as:
- Residency
- Internship
- Equivalent clinical experience

Core Competencies

Clinical safety assessment
Medical review expertise
Aggregate safety reporting
Signal detection & evaluation
Regulatory compliance
Risk management planning
Medical monitoring
Therapeutic area expertise
Leadership & mentoring
Scientific communication
Cross-functional collaboration

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Senior Physician, Patient Safety

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