Safety & Pv Specialist I - Literature Review

Syneos Health

0-2 years

Not Disclosed

Gurgaon, Gurugram, 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 & PV Specialist I – Literature Review

Company: Syneos Health®
Location: Gurgaon, India
Job ID: 25111537
Updated: September 1, 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 experience and expertise to understand customer needs and represent those needs in the solutions they shape.

Whether working in 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

Focus on employee development through career development and progression.
Supportive and engaged line management.
Technical and therapeutic-area training.
Peer recognition and total rewards programs.
Commitment to 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 customer impact and accelerating patient progress.

Job Responsibilities

1. ICSR Receipt, Tracking & Processing

Enter information into PVG quality and tracking systems for receipt and tracking of Individual Case Safety Reports (ICSRs), as required.
Assist in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
Triage ICSRs.
Evaluate ICSR data for:
- Completeness
- Accuracy
- Regulatory reportability
Enter ICSR data into the safety database.
Identify information that needs to be queried.
Follow up on queries until the required information is obtained and queries are satisfactorily resolved.

2. Medical Coding & Case Data Management

Code:
- Events
- Medical history
- Concomitant medications
- Tests
Perform drug coding as required.
Perform MedDRA coding as required.
Maintain the drug dictionary as required.
Perform manual recoding of un-recoded product and substance terms arising from ICSRs.

3. Narrative Writing & Safety Reporting

Compile complete narrative summaries.
Assist in the generation of timely, consistent, and accurate expedited reports.
Ensure expedited reporting is performed in accordance with applicable regulatory requirements.
Apply relevant safety reporting regulatory intelligence maintained by Syneos Health to safety reporting activities.

4. Literature Screening & Review

Perform literature screening for safety information.
Review literature for relevant safety information.
Support identification and processing of safety information identified through literature.
Perform drug coding and MedDRA coding as required.
Support maintenance of the drug dictionary.

5. xEVMPD Activities

Perform validation and submission of xEVMPD product records.
Ensure appropriate coding of indication terms using MedDRA.
Support activities related to xEVMPD product record management.

6. Duplicate ICSR Management

Identify potential duplicate ICSRs.
Perform identification and management of duplicate ICSRs.
Ensure duplicate cases are appropriately assessed and managed according to applicable procedures.

7. SPOR / IDMP Activities

Perform activities related to SPOR / IDMP.
Support relevant product, substance, and regulatory data activities.
Ensure appropriate handling of applicable product information.

8. ICSR Quality Review

Perform quality review of ICSRs.
Ensure case information is complete, accurate, and consistent.
Support overall quality and compliance of safety case processing.

9. Safety Tracking

Maintain safety tracking for assigned activities.
Ensure assigned safety activities are appropriately tracked and completed within required timelines.

10. TMF & PSMF Documentation

Ensure all relevant documents are submitted to the Trial Master File (TMF) according to company SOPs and sponsor requirements for clinical trials.
Ensure appropriate documentation is submitted/maintained in the Pharmacovigilance System Master File (PSMF) for post-marketing programs, as appropriate.

11. SOP, GCP, GVP & Regulatory Compliance

Maintain understanding of and compliance with:

Company Standard Operating Procedures (SOPs)
Work Instructions (WIs)
Global drug regulations
Global biologic regulations
Global device regulations
Good Clinical Practice (GCP)
ICH guidelines
Good Pharmacovigilance Practices (GVP)
Project/program plans
Drug development process

12. Collaboration & Communication

Foster constructive and professional working relationships with all project team members.
Collaborate with both internal and external stakeholders.
Work effectively in cross-functional project environments.
Maintain professional communication with project teams.

13. Audits

Participate in audits as required or appropriate.
Support compliance with audit requirements.
Ensure assigned activities and documentation are maintained appropriately.

14. Regulatory Intelligence

Apply safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.
Maintain awareness of applicable regulatory expectations relevant to assigned safety activities.

Qualifications

Educational Qualifications

Candidates should have one of the following:

Bachelor’s Degree in Life Sciences; or
Registered Nurse; or
Pharmacist; or
Equivalent combination of education and experience that provides the necessary knowledge, skills, and abilities to perform the job.

Technical & Functional Knowledge

Knowledge of safety database systems is required.
Knowledge of medical terminology is required.
Good understanding of clinical trial processes across Phase II–IV and/or post-marketing safety requirements.
Good understanding of:
- ICH GCP
- GVP
- Safety and Pharmacovigilance regulations

Computer & Software Skills

Proficiency in:

Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Microsoft Visio
Microsoft Outlook / Email
Team Share or another management/shared content/workspace platform
Internet and web-based tools

Professional Skills

Ability to work independently.
Ability to work effectively in a team environment.
Excellent written and verbal communication skills.
Excellent interpersonal skills.
Good organizational skills.
Proven ability to prioritize work.
Ability to manage multiple tasks and projects.
Strong attention to detail.
High degree of accuracy.
Ability to meet deadlines.

Key Skills / ATS Keywords

Pharmacovigilance

Pharmacovigilance
Drug Safety
ICSR
ICSR processing
ICSR triage
ICSR tracking
Safety database
Safety case processing
Safety reporting
Expedited reporting
Case follow-up
Query management
Duplicate management
ICSR quality review

Literature Review

Literature screening
Literature review
Safety literature review
Pharmacovigilance literature surveillance
Safety information identification
Case identification from literature

Medical Coding

MedDRA
MedDRA coding
Drug coding
Medical history coding
Concomitant medication coding
Event coding
Test coding
Product coding
Substance coding
Drug dictionary maintenance
Manual recoding

Regulatory & Compliance

GCP
GVP
ICH guidelines
Safety regulations
Pharmacovigilance regulations
Regulatory reportability
Regulatory intelligence
SOPs
Work Instructions
Clinical trial regulations

Regulatory Data

xEVMPD
SPOR
IDMP
Product record validation
Product record submission
Indication coding
Product/substance data management

Documentation

TMF
PSMF
Safety documentation
Audit participation
Quality review

Clinical Development Knowledge

Phase II clinical trials
Phase III clinical trials
Phase IV clinical trials
Post-marketing safety
Drug development process

Core Competencies Expected

Attention to detail
Accuracy
Time management
Prioritization
Multitasking
Communication
Teamwork
Independent working
Organizational skills
Deadline management
Professional interpersonal skills

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 – Pharmacovigilance & Safety

Roles within the Pharmacovigilance & Safety job family are responsible for providing expertise on pharmacovigilance services.

Responsibilities may include participating in all aspects of the medical safety team's involvement in assigned trials, such as:

Performing medical review and clarification of trial-related Adverse Events.
Providing aggregate reviews of safety information.
Serving as an internal consultant to pharmacovigilance case-processing teams.
Providing and contributing to trends and safety signal detection.
Supporting risk management assessment.
Providing safety support to clinical development teams.

Impact & Contribution

These roles involve individual contributors with responsibility in a professional or technical discipline or specialty.

The role may involve:

Managing two or fewer employees.
Directing the work of lower-level professionals.
Managing processes and programs.
Contributing to the design, implementation, or delivery of processes, programs, and policies.
Applying knowledge and skills typically acquired through advanced education.

This position is described as an entry-to-developing individual contributor role.

The role generally involves:

Delivering work of limited scope.
Working on smaller and less complex projects.
Applying theoretical knowledge of a professional area.
Using knowledge typically obtained through education and/or prior experience.

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 the recruitment and employment of its employees.

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

Application

Apply for this job

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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