# Clinical Safety and PSS Operations Assistant

**Company**: Fortrea
**Location**: Tokyo
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Tokyo/Specialist-II--PSS_261460?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_9525bdb2-786

## Description

We are seeking a Clinical Safety and PSS Operations Assistant to support our operations in Tokyo or Osaka. The successful candidate will assist with the overall Clinical Safety and/or PSS operations associated with products, including the entire adverse events process.

**Job Overview** The Clinical Safety and PSS Operations Assistant will manage and process adverse events to the required standard and submit them to clients and regulatory agencies within agreed timelines. The post holder will provide this service to clients either as a support function to client project groups or as a standalone business.

**Responsibilities**

- Manage the receipt and processing of all adverse event reports

- Submit expedited Serious Adverse Event (SAE) reports to clients, Regulatory Authorities, and Ethics Committees

- Ensure all cases that require expediting reporting to worldwide Regulatory Agencies are prioritized for processing and submission

- Prepare timely pharmacovigilance reports, including Individual Case Summary Reports (ICSRs) and Periodic Reports (PRs)

- Perform peer/independent QC of Safety reports as needed

- Work with Data Management or clients on reconciliation of safety databases

- Maintain a strong understanding of Fortrea's safety database conventions and client-specific database conventions

- Assist in signal detection, trend, and pattern recognition activities

- Support/train less experienced safety staff in all aspects of case-handling and adverse event reporting

- Participate in project team and client meetings and liaise with clients

**Qualifications**

- Non-degree + 2-3 years of Safety experience or 5 years of relevant experience

- Associate degree + 2-3 years of Safety experience or 4 years of relevant experience

- BS/BA + 2 years of safety experience or 3-4 years of relevant experience

- MS/MA + 2 years of safety experience or 2-3 years of relevant experience

- PharmD + 2 years of safety experience or 2-3 years relevant experience

**Experience**

- Good verbal and written communication skills and good presentation skills

- Ability to interact and influence with line and middle management, staff, and external contacts

- High degree of accuracy with attention to detail

- Functions as a team player

- Ability to present and share useful business information across departments and functions

- Knowledge of medical and drug terminology

- Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation

- Knowledge of ICH Guidelines

**Preferred Qualifications**

- Degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related area

## Skills

### Required
- Good Clinical Practice (GCP)
- ICH Guidelines
- Medical terminology
- Pharmacovigilance
- Safety reporting

### Nice to have
- Medical Device reporting
- Worldwide regulatory requirements

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Tokyo/Specialist-II--PSS_261460?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)