Safety & Pharmacovigilance Coordinator II - Based in Sofia Area

📋 Description

• • Syneos Health is a leading integrated biopharmaceutical solutions organization dedicated to accelerating customer success by translating unique clinical, medical affairs, and commercial insights into tangible outcomes that address modern market realities.
• • Our Clinical Development model places the customer and patient at the core of our operations, with a continuous drive to simplify and streamline our work, making Syneos Health both an easy partner to engage with and an exceptional place to work.
• • Join a global team of passionate problem solvers who innovate collaboratively to help our customers achieve their therapeutic goals, embodying our commitment to agility and accelerating the delivery of life-changing therapies.
• • The Safety & Pharmacovigilance Coordinator II plays a critical role in ensuring the safety and integrity of clinical trial data by meticulously assisting with the preparation and processing of Individual Case Safety Reports (ICSRs).
• • This role demands strict adherence to all applicable data privacy guidelines, Good Clinical Practices (GCP), relevant regulatory guidelines, and both company and project-specific Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• • A key responsibility involves monitoring and accurately routing incoming safety-related information to the appropriate project teams, ensuring timely and efficient communication flow.
• • The coordinator is responsible for the comprehensive documentation and tracking of all ICSRs in strict accordance with sponsor specifications, including the management of incoming mail and faxes related to safety data.
• • A crucial aspect of the role is the meticulous redaction of patient-identifying information and images, ensuring full compliance with data protection regulations and ICH GCPs and Good Vigilance Practices (GVP).
• • Data entry into the safety database is a core function, requiring precision and adherence to both sponsor-specific guidelines and Syneos Health's internal standards to maintain data accuracy and consistency.
• • The position involves the creation, tracking, retention, and ongoing maintenance of both paper and electronic safety files, ensuring organized and accessible records.
• • Management of the translation process for any source documents that require translation is also a key duty, facilitating global data comprehension.
• • Proactive engagement in requesting follow-up safety information as appropriate is essential for comprehensive case assessment and reporting.
• • The role includes assisting with the preparation of study-specific forms and templates, contributing to the standardization and efficiency of safety documentation.
• • Support for submission processes, as instructed, is required, contributing to the timely regulatory review of safety data.
• • Daily workflow reconciliation is performed to ensure all safety-related tasks are completed accurately and on schedule.
• • Maintaining a thorough and up-to-date understanding of SOPs, WIs, global drug, biologic, and device regulations, GCPs, ICH guidelines, and the broader drug development process is fundamental to the role's success.
• • This position offers an opportunity to contribute significantly to patient safety within the pharmaceutical development lifecycle, working within a supportive and globally connected team.
• • You will be instrumental in upholding the highest standards of pharmacovigilance, ensuring that potential safety signals are identified and managed effectively, thereby contributing to the overall success of clinical trials and the development of new therapies.
• • The role requires a proactive approach to learning and adapting to evolving regulatory landscapes and company procedures.
• • Collaboration with cross-functional teams, including clinical operations, regulatory affairs, and data management, will be a regular part of the job, fostering a holistic approach to safety monitoring.
• • Attention to detail and a commitment to accuracy are paramount in all aspects of this role, given the critical nature of safety reporting.
• • The ability to manage multiple tasks simultaneously and prioritize effectively in a fast-paced environment is essential for success.
• • This role is based in the Sofia Area and offers a remote working arrangement, providing flexibility and work-life balance.
• • You will be part of a company that is passionate about developing its people, offering career development, supportive management, and comprehensive training programs.
• • Embrace our 'Total Self' culture, where authenticity is valued, and contribute to building a workplace where everyone feels they belong.
• • Your work here truly matters everywhere, as you contribute to bringing essential therapies to patients worldwide.