**Description**
**Senior Safety & PV Operations Specialist**
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
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 accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
**WORK HERE MATTERS EVERYWHERE**
**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 our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
**Job responsibilities**
General
- Develops and maintains a repository of all relevant documents (e.g., Training, Safety and Pharmacovigilance Project Finance, Proposals tracking (awards and losses), RFI Library, departmental metrics, lists of audits/inspections).
- Develops and maintains Job Aids and process documents and maintains supporting documentation for these documents as needed.
- Maintains knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and PV reporting.
- 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.
- Provides SPVG 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 15%)
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 and performance of quality control activities.
- Facilitates the activities of Quality Assurance by identifying and communicating areas of risk through risk-based process assessments;
- 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.
Training
- Plans, develops, creates, tracks, and presents the training materials (planned or ad hoc) for the Safety and Pharmacovigilance BU. Liaises with Safety and Pharmacovigilance leadership 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) oversight for Safety and Pharmacovigilance.
- Develop PV specific training for inclusion in an accreditation program.
Technology
- Participates in audits and performs system demos when necessary.
- Participates in the Safety implementation/validation of Safety Systems projects (including creating, performing, and documenting), testing and documentation.
- Participates in the development and maintenance of departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs) related to Safety Systems.
- Comprehensive understanding of IT SOPs and WIs that impact the business processes associated with Safety Systems.
- Analyzes and assists with programs for internal and external regulatory or customer report needs from Safety Systems
- Implements department efficiencies l related to Safety and Pharmacovigilance processes.
- Configures, administers, and maintains the Argus Safety database on a per project basis to ensure sponsor specific requirements are met.
- Participates in the development, validation/ testing, and maintenance of all Safety reporting tools (e.g. Business Object