Drug Safety Jobs in Brazil.
All active Drug Safety roles based in Brazil.
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Drug Safety Specialist
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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 & Responsibilities:
- Process ICSRs according to SOPs and project-specific safety plans
- Triages ICSRs, evaluates data for completeness and regulatory reportability
- Enter data into Argus Safety Database
- Code events, medical history, concomitant meds, and tests
- Draft case narratives
- 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
- Attend department meetings
- Participate in project meetings
- Other duties as assigned
Education and Experience:
Minimum 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 regulations
- Professional working proficiency in English
Preferred Education & Experience:
- Early phase oncology experience preferred
Knowledge, 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 deadlines
Any 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 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 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.
Ready to apply?
Apply to Precision for Medicine
Drug Safety Specialist
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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 & Responsibilities:
- Process ICSRs according to SOPs and project-specific safety plans
- Triages ICSRs, evaluates data for completeness and regulatory reportability
- Enter data into Argus Safety Database
- Code events, medical history, concomitant meds, and tests
- Draft case narratives
- 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
- Attend department meetings
- Participate in project meetings
- Other duties as assigned
Education and Experience:
Minimum 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 regulations
- Professional working proficiency in English
Preferred Education & Experience:
- Early phase oncology experience preferred
Knowledge, 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 deadlines
Any 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 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 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.
Ready to apply?
Apply to Precision Medicine Group
Drug Safety Associate Consultant
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Job Description
Job Title: Senior Executive / Specialist - Case Processing
Employment Type: Contract
Location: Brazil (Remote)
About ClinChoice
ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.
Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.
We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.
Primary Responsibilities:
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Candidate Profile:
- Bachelor’s or Master’s in Pharmacy / Life Sciences or above and in alignment with project / business team requirements.
- Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream.
- Must have hands on experience with MS office applications (Outlook, Excel, Word, Power Point etc.).
- Must be able to Write and speak Japanese.
- Dynamic working hours.
Ready to apply?
Apply to ClinChoice