# Safety & PV Specialist I - Japanese Language expert

**Company**: Syneos Health
**Location**: Gurugram, IND
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Gurugram/Safety---PV-Specialist-I_25104761?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_edd5063b-2da

## Description

Syneos Health is seeking a Safety & PV Specialist I - Japanese Language expert. As a Safety & PV Specialist, you will play a critical role in ensuring the safety of pharmaceutical products.

**Job Responsibilities**

- 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, and regulatory reportability.

- Enter data into safety database, code events, medical history, concomitant medications, and tests.

- Compile complete narrative summaries and identify information to be queried.

- Assist in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.

- Maintain safety tracking for assigned activities.

- Perform literature screening and review for safety, drug coding, and maintenance of drug dictionary.

- Validate and submit xEVMPD product records, including coding of indication terms using MedDRA.

- Participate in activities related to SPOR / IDMP and quality review of ICSRs.

**Qualifications**

- Bachelor's Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience.

- At least JLPT N3 Certification in Japanese language.

- Knowledge of safety database systems and medical terminology required.

- Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements.

- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share, and internet.

- Ability to work independently and in a team environment with excellent communication and interpersonal skills.

**What We Offer**

Syneos Health offers a dynamic work environment with opportunities for career growth and development. The company is committed to building an inclusive culture where employees can authentically be themselves.

## Skills

### Required
- Japanese
- Safety Database systems
- Medical terminology
- Clinical trial process
- ICH GCP
- GVP
- Regulatory requirements

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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---PV-Specialist-I_25104761?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)