Safety & PV Specialist - Future Roles (Mexico)Updated: YesterdayLocation: MEX-Mexico City-HybridJob ResponsibilitiesEnter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.
TriagesICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
Enters data into safety database.Codes events, medical history, concomitant medications, and tests.
Compiles complete narrative summaries.
Identifiesinformation to be queried and follows up until information is obtained and queries are satisfactorily resolved.
Assists inthe generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicableregulatory requirements.Maintains safety tracking for assigned activities.Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.Manual recoding of un-recoded product and substance terms arises from ICSRs.Identification and management of duplicate ICSRs.Activities related to SPOR / IDMP.Quality review of ICSRs.Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements forclinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.Maintains understanding and compliance with SOPs, Work Instructions (WIs), integral drug/biologic/device regulations, GCP,ICH guidelines, GVP,



project/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.QualificationsBachelor'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 knowledge of medical terminology required.Good understanding of clinical trial process 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, and 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 work on multiple tasks and projects.Detail oriented with a high degree of accuracy and ability to meet deadlines.Additional InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive.
The Company, at itssole discretion and with no prior notice, may assign other tasks,



duties, and job responsibilities.
Equivalentexperience, skills, and/or education will also be considered so qualifications of incumbents may differ fromthose listed in the Job Description.
The Company, at its sole discretion, will determine what constitutes asequivalent to the qualifications described above.
Further, nothing contained herein should be construedto create an employment contract.
Occasionally, required skills/experiences for jobs are expressed in briefterms.
Any language contained herein is intended to fully comply with all obligations imposed by thelegislation 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 withthe Americans with Disabilities Act, including the provision of reasonable accommodations, whenappropriate, to assist employees or applicants to perform the essential functions of the job.Syneos Health is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment withoutregard 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 notbe discriminated against.
If you are an individual with a disability who requires reasonable accommodation tocomplete any part of our application process, including the use of this website, please contact us at: Email:****** One of our staff members will work with you to provide alternate means to submit yourapplication.
#J-*****-Ljbffr

📌 Safety & Pv Specialist - Future Roles (Mexico) (Xico)
🏢 Syneos Health
📍 Xico