Safety & Pv Coordinator

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 Coordinator

Company: Syneos Health®
Location: Gurgaon, India
Job ID: 25112047
Updated: Today

About Syneos Health

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

Our 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 we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Why Syneos Health

We are passionate about developing our people through career development and progression, supportive and engaged line management, technical and therapeutic-area training, peer recognition, and total rewards programs.
We are committed to building an inclusive culture where you can authentically be yourself.
Our purpose, Driven to Deliver, captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
We are continuously building the company we all want to work for and our customers want to work with.
By bringing together smart colleagues from around the world, we can shape the future of healthcare, drive impact for customers, and define the pace of patient progress.

Job Responsibilities

1. PV Quality & ICSR Tracking

Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs as required.
Maintain safety tracking for assigned activities.
Assist in ensuring accurate and timely documentation of safety activities.

2. ICSR Processing

Assist in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.
Triage ICSRs.
Evaluate ICSR data for completeness, accuracy, and 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.
Identify and manage duplicate ICSRs.
Perform quality review of ICSRs.

3. Medical Coding

Code events, medical history, concomitant medications, and tests.
Perform MedDRA coding as required.
Perform drug coding as required.
Maintain the drug dictionary as required.
Manually recode un-recoded product and substance terms arising from ICSRs.
Ensure appropriate coding of relevant medical and product information.

4. Narrative Writing

Compile complete and accurate narrative summaries for ICSRs.
Ensure narratives appropriately reflect the available case information.
Support consistent and accurate case documentation.

5. Expedited Safety Reporting

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

6. Literature Screening

Perform literature screening for safety information.
Review literature for relevant safety information as required.
Support identification and processing of potential safety cases arising from literature.
Perform literature-related drug coding and pharmacovigilance activities as required.

7. xEVMPD Activities

Perform validation and submission of xEVMPD product records.
Ensure appropriate coding of indication terms using MedDRA.
Support product data quality and regulatory requirements related to xEVMPD.
Perform activities associated with product record maintenance as required.

8. SPOR / IDMP Activities

Support activities related to SPOR / IDMP.
Maintain appropriate product and substance information in accordance with applicable requirements.
Support regulatory data management activities associated with SPOR/IDMP.

9. Duplicate Management & Quality Review

Identify potential duplicate ICSRs.
Perform appropriate duplicate assessment and management.
Conduct quality review of ICSRs.
Ensure case information is complete, accurate, consistent, and compliant with applicable requirements.

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 relevant documentation is maintained within the Pharmacovigilance System Master File (PSMF) for post-marketing programs, as appropriate.
Maintain appropriate safety documentation in accordance with applicable procedures.

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 processes
Applicable regulatory requirements

12. Collaboration & Stakeholder Management

Foster constructive and professional working relationships with all project team members.
Collaborate effectively with internal and external stakeholders.
Support cross-functional project activities.
Communicate professionally and effectively with project teams and relevant stakeholders.

13. Audits & Inspection Readiness

Participate in audits as required or appropriate.
Support compliance with audit and inspection requirements.
Ensure assigned activities and documentation are maintained in accordance with applicable quality standards.

14. Regulatory Intelligence

Apply safety reporting regulatory intelligence maintained by Syneos Health to all applicable safety reporting activities.
Maintain awareness of relevant regulatory requirements and their impact on safety activities.

Key Skills & Technical Competencies

Pharmacovigilance / Drug Safety

Individual Case Safety Report (ICSR) processing
ICSR intake and tracking
ICSR triage
ICSR assessment
Regulatory reportability assessment
Safety database entry
Case follow-up
Query management
Duplicate case management
ICSR quality review
Expedited safety reporting
Safety tracking

Medical Coding

MedDRA coding
Adverse event/event coding
Medical history coding
Concomitant medication coding
Test coding
Drug coding
Product coding
Substance coding
Drug dictionary maintenance
Manual recoding

Regulatory & Compliance

GCP
GVP
ICH guidelines
SOPs
Work Instructions
Global drug/biologic/device regulations
Regulatory reportability
Regulatory intelligence
Safety reporting requirements

Regulatory Data Management

xEVMPD
SPOR
IDMP
Product record validation
Product record submission
Indication coding using MedDRA
Product and substance data management

Documentation & Quality

TMF
PSMF
ICSR quality review
Safety documentation
Audit participation
Quality and compliance activities

Other Relevant Skills

Literature screening
Literature review
Narrative writing
Query follow-up
Cross-functional collaboration
Stakeholder management
Drug development knowledge

Candidate Profile

The role is suitable for candidates with relevant experience and/or knowledge in:

Pharmacovigilance
Drug Safety
ICSR processing
Clinical safety
Post-marketing safety
Safety database operations
Medical coding
MedDRA
Regulatory safety reporting
Literature screening
Narrative writing
Case quality review
Duplicate management
GCP
GVP
ICH guidelines
xEVMPD
SPOR / IDMP
TMF / PSMF documentation

About 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 across
73,000 sites
675,000+ trial patients

No matter what your role is, you’ll take the initiative and challenge the status quo with Syneos Health in a highly competitive and ever-changing environment.

Additional Information

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

Syneos Health, 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 employees or applicants 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 with additional career opportunities.

Company Website

Syneos Health: syneoshealth.com

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Safety & Pv Coordinator

Job Description

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