12 August, 2022
Syneos Health is Hiring Safety & PV Ops Specialist I – (PL/SQL experience)
Safety & PV Operations Specialist I
JOB TITLE: Safety & PV Operations Specialist I
SELECT ONE: Clinical Development Services
REPORTS TO:Manager or designee, Safety & Pharmacovigilance Group
Assists in providing operational support in multiple areas within the Safety & Pharmacovigilance Business Unit (BU). Assists in the preparation of information for training materials, proposal development, training certifications, quality & compliance. Assist in the preparation of the departmental metrics to support KPI’s and dashboards. Assists in providing systems support related to the safety database and other technological applications utilised by SPVG.
- Assists in providing operational support to the relevant departments within the Business Unit.
- Maintains repository of all relevant documents (e.g. Training, Project Finance, Proposals tracking [awards and losses], RFI Library, departmental metrics, list of audits/inspections).
- Develops and maintains job aids and process documents and maintains supporting documentation for these documents as needed.
- Ensures compliance to Standard Operating Procedures (SOP), Policies and SMP documents
- Plays an active role in helping to strengthen PV operations.
- Maintains knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting.
- Supports Annual Gross Profit percentage (GP%) targets by working with the operational team members to ensure an appropriate understanding of the factors that drive GP% for the units in RBB.
- Assists in the preparation of information for the Executive Project Reviews and the monthly Safety & Pharmacovigilance finance meeting
- Performs other work-related duties as assigned
- Minimal travel may be required (up to 5%).
Quality & Compliance
- Facilitates the activities of Quality Planning by providing controlled document support per development, revision, or review; provides support for development of department or client-specific documents; track and communicate quality metrics to assess, evaluate, and facilitate team/individual achievement to the expected level of quality.
- Facilitates the activities of Quality Compliance verification of performance of quality control activities.
- Facilitates the activities of Quality Assurance by identifying and communicating areas of risk through risk-based process assessments;
- Facilitates the activities of Quality Improvement by 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.
- Participates in evaluation, escalation, and resolution of SPVG potential quality issues. May collaborate with management and internal Corporate Quality Assurance to monitor and ultimately bring to resolution any open quality issues and ensure appropriate implementation of CAPAs
- Assists the safety project teams in maintaining audit and inspection readiness. Participates in internal audits, client audits, or inspections.
- Assists in the tracking and analysis of quality metrics for the Safety & Pharmacovigilance BU
- Assists in the creation, tracking and presentation of the training materials (planned or ad hoc) within the Safety and Pharmacovilance BU. Collaborates with Safety and Pharmacovigilance personnel (Directors and above) to identify appropriate content for inclusion of new or updated training materials (e.g., Safety Specialist/Safety Coordinator training, revenue recognition and forecasting training).
- Assist with the management and maintenance of the safety database, including but not limited to:
- User set-up and maintenance
- Project-specific configurations
- Routine safety database patches and updates
- Routine MedDRA and WHO drug dictionary updates
- Performance qualification (PQ) scripts for safety database updates/changes
- Maintenance of systems to ensure compliance with reporting requirements
- Assist with the management and maintenance of other SPVG applications (e.g. SharePoint).
- Assist with project support related to safety database issues and data outputs.
- Assist with the execution and validation of safety data migrations into the safety database.
- Generate listings, reports and queries from the safety database for internal, client, or regulatory use.
- Ensure compliance with applicable regulatory requirements, company policies, procedures, and standards.
- Assist with other SPVG initiatives as needed.
- Supports Annual Revenue targets by working with the operational team members and Therapeutic BU Project Managers / Project Directors to ensure accurate and timely recognition of the BU in RBB.
- Supports Plan Activation Strategy calls and assists in development of proposal strategy by collaborating with leadership.
- Assists in updating the proposal template text and slides with periodic reviewing and updating of elements.
- Assists in the maintenance and updating of elements of the costing model including reviewing project budget information on an ongoing basis to ensure hours and tasks in the cost model are realistic when compared with actual project financial information.
- Assists with the oversight of Change Order activities
What we’re looking for
- Bachelor’s degree in life science, registered nurse, pharmacist, computer science or other technology related field (technical role) ,or equivalent combination of education and experience.
- Safety Database systems and moderate medical terminology required
- Excellent knowledge of ICH guidelines and regulations relating to safety and pharmacovigilance.
- Proficiency in Microsoft Office Suite (Word, Excel, Visio, and PowerPoint), email (Outlook), and internet.
- Ability to work independently and in a team environment
- Ability to successfully prioritize and work on multiple tasks
- Excellent communication, presentation, interpersonal skills, both written and spoken
- Strong organizational and documentation skills
- Detail oriented with a high degree of accuracy and ability to meet deadlines
- Able to make effective decisions
- Manage multiple priorities
- Minimal travel may be required