Safety & PV Coordinator II * Hybrid SPAIN *

Safety & PV Coordinator II – Hybrid SPAIN Updated: January 19, 2026 Location: Madrid, Spain Job ID: -OTHLOC-3651-2DH 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 places the customer and the patient at the center of everything we do. We continuously look for ways to simplify and streamline our work so we can be easier to work with and 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. Benefits 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? 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 Responsible for assisting with departmental or project deliverables associated with the preparation and the processing of Individual Case Safety Reports (ICSRs), literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding, data management activities which include cleansing and validation of data (xEVMPD product dictionary, manual recoding of substance/product terms arising from ICSR reports, management of duplicate ICSR cases, quality review of ICSSRs, Substances, Products, Organizations and Referential (SPOR), Identification of Medicinal Products (IDMP) activities) and the preparation of expedited and periodic safety reports, while adhering to all data privacy guidelines, Good Clinical Practices (GCP), regulatory guidelines, and company and project-specific procedures. Monitors and routes incoming information to the appropriate project if required. Records all ICSR documentation and tracks in accordance with Sponsor/customer specifications; distributes incoming mail and faxes if required. Redacts patient identifying information/images in accordance with data protection guidelines, ICH GCP and GVP if required. Enters data into the safety database in accordance with Sponsor/customer specific guidelines and Company standards if required. Ensures current conventions are followed when entering cases into the Safety database. May perform file creation, tracking, retention, and maintenance (paper and electronic). Manages the translation process for any source documents requiring translation if required. Performs or assists with query follow up process as instructed. Assists with submission processes as required. Assists with daily workflow reconciliation. Assists with literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding if required. Assists with narrative writing. Assists with coding events, medical history, concomitant medications, and tests. Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements. Validates xEVMPD product records, including appropriate coding of indication terms using MedDRA if required. Manually recodes un-recoded product and substance terms arising from ICSSRs if required. Identifies and manages duplicate ICSSRs if required. Activities related to SPOR / IDMP if required. Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. Maintains understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study/program plans and the drug development process. Fosters constructive and professional working relationships with all project team members, internal and external. Participates in audits as required/appropriate. Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities. Qualification Requirements Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job. Safety Database systems and medical terminology preferred. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, email (Outlook), Team Share (or another shared content/workspace) and internet. Works with others as part of a team. Ability to successfully prioritize and work on multiple tasks. Excellent communication and interpersonal skills, both written and spoken. Strong organizational and documentation skills. Detailed oriented with a high degree of accuracy. Additional Information 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. 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. Syneos Health is an equal opportunity employer. We encourage people of all backgrounds and experiences to apply. The Company provides a supportive environment for employees and applicants to foster a diverse and inclusive culture. #J-18808-Ljbffr