Drug Safety Specialist (San Carlos de Bariloche)
Precision Medicine Group
- San Carlos de Bariloche, Río Negro
- Permanente
- Tiempo completo
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 & Responsibilities:Process ICSSRs according to SOPs and project‑specific safety plans
Triages ICSSRs, evaluates data for completeness and regulatory reportability
Enter data into Argus Safety Database
Code events, medical history, concomitant meds, and tests
Query resolution and follow‑up until complete
Generate timely expedited regulatory reports
Coordinate reconciliation of safety and clinical databases
Ensure required safety reports distribution
Participate in audits/inspections
Submit documents to TMF/PV System MF
Maintain compliance with SOPs, GCP, ICH, GVP, regulations
Participate in project meetings
Other duties as assignedEducation and 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 regulations
Professional working proficiency in EnglishPreferred Education & Experience:Early phase oncology experience preferredKnowledge, Skills, and Competencies:Strong knowledge of safety reporting requirements and guidelines
Ability to analyze and evaluate clinical safety data
Strong written communication and narrative writing skills
Experience with Argus, MedDRA, WHODrug
Strong attention to detail
Ability 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 reg
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