Updated: March 13, 2025 Location: Colombia-Latin America - COL-Home-Based Job ID: 25001801 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 about changing 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 • 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 with 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 • Assists 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. • Assists with the management and maintenance of other SPVG applications (e.g., SharePoint). • Provides project support related to safety database issues and data outputs for Safety & PvG projects utilizing the Syneos Health safety database. • Assists with the execution and validation of safety data migrations into the safety database. • Generates listings, reports, and queries from the safety database for internal, client, or regulatory use. • Participates in project meetings as requested. • Ensures compliance with applicable regulatory requirements, company policies, procedures, and standards. • Maintains a high level of expertise regarding Safety & PvG systems and applications through participation in internal meetings and professional seminars and workshops. • Assists 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 the 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. Qualifications 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. 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. Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Syneos Health is a leading 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. Together we share insights, use the latest technologies, and apply advanced business practices to speed our customers’ delivery of important therapies to patients. #J-18808-Ljbffr