Job Title

Updated:Yesterday Location:MEX-Remote Job ID: 25107722Safety & PV Coordinator – Mexico Remote Job ResponsibilitiesEnter information into PVG quality and tracking systems for receipt and tracking ICSR as required. Assist in the processing of IC/RSs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. Triage IC/RSs, evaluate ICSR data for completeness, accuracy, and regulatory report ability. Enter data into safety database. Code events, medical history, concomitant medications, and tests. Compile complete narrative summaries. Identify information to be queried and follow up until information is obtained and queries are satisfactorily resolved. Assist in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.Maintain safety tracking for assigned activities.Perform literature screening and review for safety, drug coding, maintenance of drug dictionary, and MedDRA coding as required.Validate and submit xEVMPD product records, including appropriate coding of indication terms using MedDRA.Manually recode un-recoded product and substance terms arising from IC/RSs.Identify and manage duplicate IC/RSs.Perform activities related to SPOR / IDMP.Conduct quality review of IC/RSs.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 and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/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 maintained by Syneos Health to all safety reporting activities.QualificationsBachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that provides the necessary knowledge, skills, and abilities to perform the job.Experience with safety database systems and knowledge of medical terminology.Good understanding of clinical trial processes across Phases II-IV and/or post‑marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance.Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet.Ability to work independently and in a team environment.Excellent communication and interpersonal skills, both written and spoken.Good organizational skills with proven ability to prioritize and manage multiple tasks and projects.Detail oriented with a high degree of accuracy and ability to meet deadlines.Syneos 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, including the use of this website, please contact us at jobs@.#J-18808-Ljbffr