# Safety & Pharmacovigilance Coordinator (1+ Year Experience in CT or Literature Data Entry)

**Company**: Syneos Health
**Experience**: mid
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Gurugram/Safety---Pharmacovigilance-Coordinator--1--Year-Experience-in-CT-or-Literature-Data-Entry-_25104873?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_1ccbbcb1-0c4

## Description

Syneos Health is seeking a Safety & Pharmacovigilance Coordinator with 1+ year of experience in CT or literature data entry.

As a Safety & Pharmacovigilance Coordinator, you will monitor and route incoming safety information to the appropriate project teams. You will record all ICSR documentation and track cases in accordance with sponsor/customer specifications, distribute incoming mail and faxes, redact patient-identifying information and images in compliance with data protection guidelines, ICH-GCP, and GVP requirements, and perform accurate and timely data entry into the safety database in accordance with customer-specific guidelines and company standards.

Responsibilities:

- Monitor and route incoming safety information to the appropriate project teams

- Record all ICSR documentation and track cases in accordance with sponsor/customer specifications; distribute incoming mail and faxes

- Redact patient-identifying information and images in compliance with data protection guidelines, ICH-GCP, and GVP requirements

- Perform accurate and timely data entry into the safety database in accordance with customer-specific guidelines and company standards

- Assist with case file creation, tracking, retention, and maintenance (paper and electronic)

- Support management of translation processes for source documents requiring translation

- Assist with query follow-up activities as instructed

- Support safety submission processes as instructed

- Assist with daily workflow reconciliation activities

- Maintain a working knowledge of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP modules, study/program plans, and the drug development process

Qualification Requirements:

- Healthcare professional by education: B.Pharm / M.Pharm / PharmD / BDS

- Minimum 1 year of experience in Pharmacovigilance in a full data entry / case processing role is mandatory

- Experience in processing Literature and Clinical Trial (CT) cases is preferred

- Experience with safety database systems and medical terminology preferred

- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook, TeamShare (or similar document management systems), and internet applications

- Strong ability to work collaboratively as part of a team

- Ability to prioritize and manage multiple tasks effectively in a fast-paced environment

- Excellent written and verbal communication and interpersonal skills

- Strong organizational and documentation skills with high attention to detail and accuracy

- Should be flexible to work in rotational shifts

Benefits:

- Career development and progression

- Supportive and engaged line management

- Technical and therapeutic area training

- Peer recognition and total rewards program

- Total Self culture – where you can authentically be yourself

## Skills

### Required
- Pharmacovigilance
- ICH-GCP
- GVP
- Medical Terminology
- Microsoft Office Suite
- Visio
- Outlook
- TeamShare

### Nice to have
- Literature and Clinical Trial (CT) cases
- Safety database systems

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Gurugram/Safety---Pharmacovigilance-Coordinator--1--Year-Experience-in-CT-or-Literature-Data-Entry-_25104873?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)