We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Safety Specialist to join our growing team!The Safety Specialist is an integral part of the safety team and performs all aspects of the collection, processing, and reporting of individual case safety reports (ICSR) for clinical trials and/or post‑marketing programs.Main Duties & ResponsibilitiesProcess ICSRs according to SOPs and project-specific safety plansTriages ICSRs, evaluates data for completeness and regulatory reportabilityEnter data into Argus Safety DatabaseCode events, medical history, concomitant meds, and testsDraft case narrativesQuery resolution and follow‑up until completeGenerate timely expedited regulatory reportsCoordinate reconciliation of safety and clinical databasesEnsure required safety reports distributionParticipate in audits/inspectionsSubmit documents to TMF/PV System MFMainta, ICH, GVP, regulationsAttend department meetingsParticipate in project meetingsOther duties as assignedEducation And ExperienceMinimum Education & Experience:Minimum 2 years clinical trial drug safety experience; Bachelor’s degree sing, Life Science, or equivalent. Experience with Argus Safety Database, MedDRA, WHODrug, FDA/EMA/ICH safety regulationsProfessional working proficiency in EnglishPreferred Education & ExperienceEarly phase oncology experience preferredKnowledge, Skills, And CompetenciesStrong knowledge of safety reporting requirements and guidelinesAbility to analyze and evaluate clinical safety dataStrong written communication and narrative writing skillsExperience with Argus, MedDRA, WHODrugStrong attention to detailAbility to manage multiple cases and deadlinesAny data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
8 days ago