# Safety & PV Specialist I

**Company**: Syneos Health
**Location**: Hyderabad
**Work arrangement**: onsite
**Experience**: mid
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/Safety---PV-Specialist-I_25103004?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_c3f08fb6-0ae

## Description

Syneos Health is seeking a Safety & PV Specialist I to join their team in Hyderabad or Gurugram. The successful candidate will have 2.5-4 years of experience in pharmacovigilance and will be responsible for processing ICSRs, maintaining safety tracking, and performing literature screening.

**Job Responsibilities**

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

- 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 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 in accordance with applicable regulatory requirements.

- 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.

- Manually recode un-recoded product and substance terms arising from ICSRs.

- Identify and manage duplicate ICSRs.

- Perform activities related to SPOR / IDMP.

- Conduct quality review of ICSRs.

- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.

- Maintain understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.

- Foster constructive and professional working relationships with all project team members, internal and external.

- Participate in audits as required/appropriate.

- Apply safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.

**Qualifications**

- 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 organisational skills with proven ability to prioritise and work on multiple tasks and projects.

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

## Skills

### Required
- Argus Data base
- Aris-G
- MedDRA
- Microsoft Office Suite
- Visio
- email
- Team Share
- internet
- Safety Database systems
- medical terminology
- clinical trial process
- ICH GCP
- GVP
- regulations related to Safety and Pharmacovigilance

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/Safety---PV-Specialist-I_25103004?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)