Safety Physician

Syneos Health

0-2 years

Not Disclosed

Yerawada, India

Openings: 15 Sept. 8, 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

Safety Physician

Company: Syneos Health®
Location: Yerawada, India
Job ID: 25111697
Updated: August 29, 2026
Job Family: Pharmacovigilance & Safety

About Syneos Health

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. The company partners with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress.

The Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those needs in the solutions they shape.

Whether joining a Functional Service Provider partnership or a Full-Service environment, employees collaborate with passionate problem solvers, innovating as a team to help customers achieve their goals.

Syneos Health is agile and driven to deliver for colleagues, customers, and, most importantly, those in need.

Why Syneos Health

Passionate about developing employees through career development and progression.
Supportive and engaged line management.
Technical and therapeutic-area training.
Peer recognition and total rewards programs.
Commitment to building an inclusive culture where employees can authentically be themselves.
Purpose-driven culture centered around Driven to Deliver.
Opportunity to work with colleagues globally to shape the future of healthcare.
Focus on driving impact for customers and defining the pace of patient progress.

Position Overview

Role: Safety Physician
Location: Yerawada, India
Primary Focus: Medical review and assessment of safety information, including Individual Case Safety Reports (ICSRs), clinical safety data, and aggregate safety reports.

The position is responsible for performing medical review of ICSRs, conducting medical assessment of safety-related data, and ensuring the medical accuracy of ICSR narratives, coding, and appropriate medical interpretation of cases.

Key Job Responsibilities

1. Medical Review of Adverse Events

Perform medical review of adverse events reported for:
- Investigational products
- Marketed products
Conduct appropriate medical assessment of reported safety information.
Ensure medical accuracy and consistency in the assessment of adverse events.
Provide appropriate medical interpretation of safety information.

2. ICSR Medical Review & Assessment

Perform medical review of Individual Case Safety Reports (ICSRs).
Conduct medical assessment of safety-related data.
Ensure medical accuracy of ICSR narratives.
Review and ensure appropriate medical interpretation of cases.
Assess the clinical relevance and consistency of case information.
Ensure appropriate medical input into case assessment and processing.

3. Medical & Safety Coding Knowledge

Maintain familiarity with:

MedDRA
WHO-DRL
Safety databases such as ARGUS
Pharmacovigilance case-processing systems
Medical terminology and safety-related coding concepts

4. Collaboration with Safety & Pharmacovigilance Teams

Work closely with Safety and Pharmacovigilance (SPVG) colleagues.
Ensure appropriate medical interpretation is applied to adverse event case assessments.
Promote consistency in medical assessment across safety cases.
Provide medical expertise to case-processing activities when required.
Collaborate with relevant internal safety stakeholders.

5. Regulatory & SOP Compliance

Ensure regulatory compliance with respect to:
- Evaluation of safety information
- Safety reporting
- Safety surveillance
Ensure compliance with applicable SOPs and project-specific requirements.
Perform activities in accordance with applicable corporate and departmental policies.
Follow Standard Operating Procedures (SOPs).
Follow Work Instructions (WIs).
Follow project-specific Operating Guidelines.

6. Safety Issue Identification & Management

Identify potential safety issues.
Communicate potential safety issues effectively to relevant stakeholders.
Assess and manage potential safety issues appropriately.
Support timely escalation and appropriate handling of safety concerns.
Apply appropriate medical judgment when evaluating potential safety signals or issues.

7. Client Interaction

Interact with client safety and medical personnel as appropriate.
Provide medical expertise and support to client teams.
Communicate safety-related medical assessments effectively.
Collaborate with clients on relevant safety and pharmacovigilance activities.

8. Clinical & Drug Development Knowledge

Stay abreast of clinical information relevant to contracted programs.
Maintain knowledge of drug development information relevant to assigned programs.
Apply current clinical and drug development knowledge to safety assessments.
Maintain awareness of information that may affect the safety profile of relevant products.

9. Aggregate Safety Reports

Provide medical review and interpretation for aggregate safety reports, including:

Annual Safety Reports
PSURs
PADERs
Other applicable aggregate safety reports

Responsibilities may include:

Reviewing aggregate safety information.
Providing medical interpretation.
Assessing consistency and clinical relevance of safety findings.
Supporting accurate and appropriate safety conclusions.

10. Continuing Medical & Pharmacovigilance Education

Maintain medical expertise through appropriate continued medical education.
Maintain pharmacovigilance expertise through appropriate internal or external education.
Stay current with developments relevant to clinical safety and pharmacovigilance.
Continue to develop knowledge of applicable safety regulations, medical concepts, and pharmacovigilance practices.

11. Mentoring & Training

Assist as a mentor for other internal safety staff.
Support training of internal safety personnel.
Provide guidance to case-processing staff.
Share medical and pharmacovigilance knowledge with relevant team members.
Support development of internal safety capabilities.

12. Policies, Procedures & Project Requirements

Perform activities in compliance with:

Applicable Corporate Policies
Departmental Policies
Standard Operating Procedures (SOPs)
Work Instructions (WIs)
Project-specific Operating Guidelines
Applicable safety and pharmacovigilance requirements

13. Additional Responsibilities

Perform other duties as assigned by management.
Support additional safety and pharmacovigilance activities according to business and project requirements.

Key Technical Skills / Knowledge Areas

Medical Safety

Medical review
Adverse event assessment
Clinical safety assessment
Safety data interpretation
Medical assessment of safety information
Safety issue identification
Safety issue management

Pharmacovigilance

Pharmacovigilance
Drug Safety
ICSR medical review
ICSR assessment
Safety surveillance
Safety reporting
Aggregate safety review

ICSR

Individual Case Safety Reports
ICSR narrative review
ICSR medical accuracy
Medical interpretation
Case assessment
Case processing support

Medical Coding & Safety Databases

MedDRA
WHO-DRL
ARGUS
Safety database systems
Medical terminology
Safety coding

Aggregate Reports

Annual Safety Reports
PSUR
PADER
Aggregate safety data
Medical interpretation of aggregate safety information

Regulatory & Compliance

SOP compliance
Work Instructions
Corporate policies
Departmental policies
Project-specific Operating Guidelines
Safety reporting requirements
Pharmacovigilance regulations

Client & Stakeholder Management

Client interaction
Safety/medical team collaboration
Cross-functional collaboration
Medical communication
Stakeholder management

Training & Development

Mentoring
Staff training
Case-processing team support
Continued medical education
Pharmacovigilance education

Core Competencies

Strong medical judgment
Clinical assessment skills
Pharmacovigilance expertise
Attention to medical accuracy
Critical thinking
Safety data interpretation
Problem identification
Effective communication
Collaboration
Mentoring and knowledge sharing
Regulatory awareness
Attention to detail
Ability to work according to SOPs and project requirements

Role Summary

The Safety Physician is responsible for providing medical expertise within pharmacovigilance and safety activities.

The core responsibility is to:

Perform medical review of ICSRs.
Conduct medical assessment of safety-related data.
Ensure medical accuracy of ICSR narratives.
Review and assess medical coding.
Provide appropriate medical interpretation of safety cases.
Review adverse events associated with investigational and marketed products.
Support safety issue identification and management.
Provide medical review of aggregate safety reports.
Collaborate with Safety and Pharmacovigilance teams.
Interact with client safety/medical personnel.
Support training and mentoring of safety staff.
Ensure compliance with applicable regulatory requirements, SOPs, policies, WIs, and project-specific guidelines.

Get to Know Syneos Health

Over the past 5 years, Syneos Health has worked with:

94% of all Novel FDA Approved Drugs
95% of EMA Authorized Products
200+ Studies
73,000 Sites
675,000+ Trial Patients

Syneos Health encourages employees to take initiative and challenge the status quo in a highly competitive and continuously changing environment.

Job Family Summary

The position is responsible for performing medical review of Individual Case Safety Reports (ICSRs), conducting medical assessment of all safety-related data, and ensuring:

Medical accuracy of ICSR narratives.
Appropriate medical accuracy and interpretation of coding.
Appropriate medical interpretation of all cases.
Consistency and quality in medical safety assessment.

Additional Information

The tasks, duties, and responsibilities listed in this job description are not exhaustive.

The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.

Equivalent experience, skills, and/or education will also be considered, so qualifications of incumbents may differ from those listed in the Job Description.

The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.

Nothing contained herein should be construed to create an employment contract.

Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which Syneos Health operates, including the implementation of the EU Equality Directive, in relation to recruitment and employment.

Syneos Health is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants in performing the essential functions of the job.

Application

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Candidates who are not ready to apply can join the Syneos Health Talent Network to stay connected to additional career opportunities.

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