Safety & PV Coordinator II ** Hybrid SPAIN **

OverviewSafety & PV Coordinator II — Hybrid SPAINSyneos 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. 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 EVERYWHEREResponsibilitiesResponsible for assisting with departmental or project deliverables associated with the preparation and 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 ICSRs, 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.Monitor and route incoming information to the appropriate project as required.Record all ICSR documentation and track in accordance with Sponsor/customer specifications; distribute incoming mail and faxes if required.Redact 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.Ensure current conventions are followed when entering cases into the Safety database.May perform file creation, tracking, retention, and maintenance (paper and electronic).Manage the translation process for any source documents requiring translation if required.Perform or assist with query follow up process as instructed.Assist with submission processes as required.Assist with daily workflow reconciliation.Assist with literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding, if required.Assist with narrative writing and coding events, medical history, concomitant medications, and tests.Assist in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.Validate xEVMPD product records, including appropriate coding of indication terms using MedDRA, if required.Manual recoding of un-recoded product and substance terms arising from ICSRs if required.Identification and management of duplicate ICSRs if required.Engage in activities related to SPOR / IDMP if required.Ensure 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.Maintain understanding of SOPs, WIs, global regulations, GCP, ICH guidelines, GVP modules, study/program plans and the drug development process.Foster constructive and professional working relationships with all project team members, internal and external.Participate in audits as required/appropriate.Apply safety reporting regulatory intelligence to all safety reporting activities.QualificationsBachelor’s Degree in life science, registered nurse, pharmacist or equivalent.Nominal clinical/clinical research experience or equivalent combination of education and experience.+2 years Safety and Pharmacovigilance experience is required.Safety Database systems and medical terminology preferred.Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email, and internet.Works with others as part of a team.Ability to prioritize and manage multiple tasks.Excellent communication and interpersonal skills, both written and spoken.Strong organizational and documentation skills.Detail-oriented with a high degree of accuracy.Get to know Syneos HealthOver 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.InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its sole discretion. Equivalent experience, skills, and/or education will be considered. The Company will determine what constitutes equivalent to the qualifications described above. This description does not create an employment contract. The Company complies with applicable laws including the EU Equality Directive and the Americans with Disabilities Act, including reasonable accommodations where appropriate.#J-18808-Ljbffr