# Safety & PV Specialist I

**Company**: Syneos Health
**Location**: Gurugram
**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/IND-Hyderabad/Safety---PV-Specialist-I---II_25110715?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_45d994a2-b22

## Description

Syneos Health is seeking a Safety & PV Specialist I. The successful candidate will be responsible for various safety-related tasks, including entering information into PVG quality and tracking systems, processing ICSRs, triaging ICSRs, evaluating ICSR data, and maintaining safety tracking.

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:

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

- Experience: Minimum 2.6 Years to 4 Years in Safety & PV Specialist role.

- Location: Gurugram-Hyderabad Office based.

## Skills

### Required
- MedDRA
- ICH guidelines
- GCP
- GVP
- SPOR / IDMP
- xEVMPD

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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-I---II_25110715?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)