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!
Main Duties & ResponsibilitiesProcess IC&S; according to SOPs and project‐specific safety plansTriages IC&S;, 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 MFMaintain compliance with SOPs, GCP, 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 in Pharmacy, Nursing, 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 deadlinesPrecision 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 in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at .
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📌 Drug Safety Specialist (México)
🏢 Precision For Medicine
📍 México