# Safety & PV Specialist (SS I) - Night Shift (Gurugram)

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

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/Safety---PV-Specialist--SS-I---SS-II---Sr-SS----Night-Shift_25110762?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_33843f9c-93c

## Description

Syneos Health is seeking a Safety & PV Specialist (SS I) to work in their Gurugram office on a night shift.

The role involves entering information into PVG quality and tracking systems, processing ICSRs, triaging and 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 processing 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 generating timely, consistent, and accurate reporting of expedited reports

- Maintain safety tracking for assigned activities

- Perform literature screening and review for safety, drug coding, and MedDRA coding

- Validate and submit xEVMPD product records

- Manage duplicate ICSRs and participate in audits as required

Qualifications:

- Education: B. Pharm / M. Pharm / BDS / BMS / MBBS

- Experience: Minimum 2.6-4 years of PV experience

- Skill for Sr Safety & PV Specialist: ICSR case processing experience along with Quality Check (QC) Experience is mandatory

Benefits:

- Career development and progression

- Supportive and engaged line management

- Technical and therapeutic area training

- Peer recognition and total rewards program

- Total Self culture

## Skills

### Required
- ICSR case processing
- Quality Check (QC)
- PV experience
- MedDRA coding
- drug coding

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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--SS-I---SS-II---Sr-SS----Night-Shift_25110762?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)