# Safety & PV Specialist- Future Roles (India)

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

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Hyderabad/Safety---PV-Specialist--Future-Roles--India-_25106956?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_0b3dca48-0b1

## Description

Syneos Health is seeking a Safety & PV Specialist to join their team in India. The successful candidate will be responsible for performing various safety-related tasks, including entering information into PVG quality and tracking systems, triaging ICSRs, evaluating ICSR data, and maintaining safety tracking for assigned activities.

Responsibilities:

- Enter information into PVG quality and tracking systems for receipt and tracking ICSR

- 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

- 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, including appropriate coding of indication terms using MedDRA

- Identify and manage duplicate ICSRs

- Participate in audits as required

- Foster constructive and professional working relationships with all project team members

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/IND-Hyderabad/Safety---PV-Specialist--Future-Roles--India-_25106956?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)