Drug Safety Specialist
New
P
Precision Medicine GroupClinical Trial Services
Remote, Argentina; Remote, Brazil; Remote, Chile; Remote, Colombia; Remote, Mexico; Remote, PeruFull-TimeMiddle
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Languages
- English
- Experience
- Minimum 2 years clinical trial drug safety experience
- Required Skills
- GCP
Requirements
- Minimum 2 years clinical trial drug safety experience
- Bachelor’s degree in Pharmacy, Nursing, Life Science, or equivalent
- Experience with Argus Safety Database
- Experience with MedDRA and WHODrug
- Knowledge of FDA/EMA/ICH safety regulations
- Professional working proficiency in English
- Strong knowledge of safety reporting requirements and guidelines
- Ability to analyze and evaluate clinical safety data
- Strong written communication and narrative writing skills
- Strong attention to detail
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
View Full Description & ApplyYou'll be redirected to the employer's site
