# Safety & PV Specialist II - Mexico Hybrid

**Company**: Syneos Health
**Work arrangement**: hybrid
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/MEX-Mexico-City-Hybrid/Safety---PV-Specialist-II---Mexico-Hybrid_25110653?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_ea7f723e-972

## Description

Syneos Health is seeking a Safety & PV Specialist II to join their team in a hybrid Mexico-based role.

The successful candidate will be responsible for entering information into PVG quality and tracking systems for receipt and tracking ICSR as required. They may also assist in the preparation of project plans such as Safety Management Plans, perform set-up, delivery, and close-out of safety and pharmacovigilance projects, and process ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.

Key responsibilities include:

- Triaging ICSRs and evaluating ICSR data for completeness, accuracy, and regulatory reportability

- Entering data into safety databases

- Coding events, medical history, concomitant medications, and tests

- Compiling complete narrative summaries

- Assessing information to be queried and following up until information is obtained and queries are satisfactorily resolved

- Participating in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements

- Coordinating with data management staff concerning reconciliation of safety data between clinical and safety databases

Syneos Health is a leading provider of life sciences services, having worked with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products over the past 5 years.

The company offers a range of benefits, including career development and progression opportunities, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards programs.

## Skills

### Required
- pharmacovigilance
- safety management
- ICSR processing
- regulatory reporting
- data management

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/MEX-Mexico-City-Hybrid/Safety---PV-Specialist-II---Mexico-Hybrid_25110653?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)