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.