# PV Specialist I or Coordinator

**Company**: Syneos Health
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/CHN-Dalian/PV-Specialist-I-or-Coodinator_25113230?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_74fb0a7c-0cd

## Description

Syneos Health is seeking a PV Specialist I or Coordinator to join their Clinical Solutions team. The successful candidate will be responsible for performing pharmacovigilance activities, including receipt and tracking of Individual Case Safety Reports (ICSRs), data entry into safety databases, and compilation of narrative summaries.

Responsibilities:

- Enter information into PVG quality and tracking systems for receipt and tracking of ICSRs

- 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

- Identify information to be queried and follow up until information is obtained and queries are satisfactorily resolved

- Assist in the generation of timely, consistent, and accurate reporting of expedited reports

- Maintain safety tracking for assigned activities

- Perform literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required

- Validate and submit xEVMPD product records

- Participate in audits as required

Qualifications:

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

- Safety Database systems and knowledge of medical terminology required

- Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance

- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet

- Ability to work independently and in a team environment

- Excellent communication and interpersonal skills, both written and spoken

- Good organizational skills with proven ability to prioritize and work on multiple tasks and projects

- Detail oriented with a high degree of accuracy and ability to meet deadlines

## Skills

### Required
- Safety Database systems
- medical terminology
- clinical trial process
- ICH GCP
- GVP
- Microsoft Office Suite
- Visio
- email
- Team Share

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/CHN-Dalian/PV-Specialist-I-or-Coodinator_25113230?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)