Safety and PV Ops Specialist II

Benefits

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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. Discover what your 25,000 future colleagues already know: Why Syneos Health - We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. - We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life. - We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 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 qualifica

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