Safety and PV Ops Specialist II

Safety And PV Ops Specialist II

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Job Responsibilities

General

• Maintains repository of all relevant documents (e.g. Training, Safety & Pharmacovigilance Project Finance, Proposals tracking [awards and losses], RFI Library, departmental metrics, and lists 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
• Maintains knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting.
• 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.
• Provides support with the preparation of information for the Executive Project Reviews and the monthly Safety & Pharmacovigilance finance meeting
• Provides metrics as appropriate at agreed upon intervals based on assigned tasks.
• Performs other work-related duties as assigned.
• Minimal travel may be required (up to 10%).

Quality & Compliance

• Supports 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.
• Supports the activities of Quality Compliance verification of performance of quality control activities.
• Supports 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
• Supports the safety project teams in maintaining audit and inspection readiness.
• Supports the tracking and analysis of quality metrics for the Safety & Pharmacovigilance BU.

Training

• Creates, tracks, and presents the training materials (planned or ad hoc) within the Safety and Pharmacovigilance 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).
• Provides Learning Management System (LMS) support for Safety and Pharmacovigilance

Technology

• 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).
• Provide project support related to safety database issues and data outputs for Safety & PvG projects utilising the Syneos Health safety database.
• 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
• Participate in project meetings as requested.
• Ensure compliance with applicable regulatory requirements, company policies, procedures, and standards.
• Maintain a high level of expertise regarding Safety & PvG systems and applications through participation in internal meetings and professional seminars and workshops
• Assist with other SPVG initiatives as needed.

Proposals

• 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.
• Supports Plan Activation Strategy calls and assists in development of proposal strategy by collaborating with leadership.
• Ensures budget, text, and scope of work for responses to Request for Proposals and Request for Information are accurate and appropriate by working with appropriate staff. Solicits input from team members and other sources to develop the proposal. Collaborates with leadership to identify appropriate named teams for inclusion in proposals.
• Develops and maintains template proposal text and slides with periodic reviewing and updating of elements.
• Assists in the maintenance and updating of the elements of the costing model including ongoing review of project budget information to ensure hours and tasks in the cost model are realistic when compared with actual project financial information
• Provides support with the oversight of Change Order activities

What we're looking for:

• At least 3 plus years of PV experience
• Strong expertise in technical writing for PV Department
• Excellent written and verbal communication skills
• Candidates with hands on experience with PDFs, Powerpoint and other office apps will be preferred

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.