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Safety & PV Coordinator II – Hybrid SpainLos candidatos deben tomarse el tiempo de leer atentamente todos los elementos de este anuncio de empleo. Por favor, envíen su solicitud sin demora.Updated: YesterdayLocation: ESP‑Madrid‑HybridJob ID: 25105012DescriptionSyneos 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.Job ResponsibilitiesAssist 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, Medical Dictionary for Regulatory Activities (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, SPOR, 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, 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.Enter 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.Engages in 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 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 RequirementsBachelor’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 management/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.Detail‑oriented with a high degree of accuracy.Equal Opportunity EmploymentSyneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, please contact us at and a staff member will work with you to provide alternate means to submit your application. xsgfvud #J-18808-LjbffrHay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.
