# Principal Safety Operations Specialist - Quality Focused

**Company**: Syneos Health
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/Principal-Safety-Operations-Specialist---Quality-Focused_25112974?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_e85350db-7f6

## Description

Syneos Health is seeking a Principal Safety Operations Specialist - Quality Focused. As a member of the Clinical Solutions team, you will act with a drug development mindset, applying your years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

**Job Responsibilities**

- Develops and maintains Job Aids and process documents and maintains supporting documentation for these documents as needed.

- Facilitates SPVG Annual Revenue targets by working with the operational SPVG team members and Therapeutic BU PMs / Project Directors, to ensure accurate and timely recognition of the BU in RBB.

- Responsible for providing SPVG metrics as appropriate at agreed upon intervals based on assigned tasks.

- Provides mentoring and training on processing and reporting of safety procedures.

- Maintains knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting.

- Provides oversight of activities and the quality and timely completion of deliverables.

- Performs other work-related duties as assigned.

**Quality & Compliance**

- Responsible for Quality Planning activities by providing controlled document support per development, revision, or review; provides support for development of department or client-specific documents; tracks and communicates quality metrics to assess, evaluate, and facilitate team/individual achievement to the expected level of quality.

- Responsible for Quality Assurance activities by identifying and communicating areas of risk through risk-based process assessments;

- Responsible for Quality Compliance verification and performance of quality control activities.

- Provides expertise for procedures and QI support. May liaise with management and internal Corporate Quality Assurance (CQA) to monitor and ultimately bring to resolution any open QIs.

- Supports the safety project teams in maintaining audit and inspection readiness.

- Responsible for Quality Improvement activities including the developing and promoting improvement initiatives; identifies and communicates deficiencies and/or deviations from company, department, or client processes; manages, tracks and/or assists with corrective and preventive action development and completion; participates in root cause analysis process.

## Skills

### Required
- FDA/EU/ICH guidelines
- safety procedures
- quality planning
- quality assurance
- quality compliance

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/Principal-Safety-Operations-Specialist---Quality-Focused_25112974?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)