# Safety & PV Specialist II

**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/IND-Hyderabad/Safety---PV-Specialist-II_25111393?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_6e721478-dcd

## Description

Syneos Health is seeking a Safety & PV Specialist II to join their team. 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 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 report ability

- 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: 4-7 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-II_25111393?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)