Drug Safety Coordinator

ALOIS Staffing; Foster City (CA); On-site; USD 40,000 - 60,000; Full time

Job summary

ALOIS Staffing is looking for a detail-oriented individual for a role involving data entry and review in a safety compliance environment. The ideal candidate will possess excellent interpersonal communication skills and proficiency in Microsoft Office, particularly Excel, PowerPoint, and Word.

This position emphasizes initiative, teamwork, and accuracy, requiring a strong ability to manage workloads and follow regulatory guidelines. Knowledge of medical terminology and safety reporting is preferred.

Qualifications

• Excellent interpersonal communication skills, both written and oral.
• Strong organizational skills and ability to adapt to change.
• A demonstrated ability to manage own workload under strict timelines.

Responsibilities

• Review, extract, and accurately enter AE data from ICSR reports.
• Ensure accuracy of data entries made by Safety Coordinators.
• Exhibit initiative, teamwork, and accountability in all tasks.

Skills

Interpersonal communication skills

Microsoft Office suite (Excel, PowerPoint, Word)

Safety database and data entry

Medical and drug terminology

Regulatory compliance

Attention to detail

Organizational skills

Job description

Job Description

• Excellent interepersonal communication skills, both written and oral
• Excellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word)
• Safety database and data entry experience preferred
• Basic understanding of medical and drug terminology preferred
• Knowledge and experience with safety reporting and regulatory compliance and experience with international safety reporting/regulations is preferred
• Demontrates initiative, teamwork and accountability
• Demonstrated success working both independently and in collaboration with others
• A quality driven individual with strong attention to detail and accuracy is required
• Strong organizational skills, and ability to adapt to change
• A demonstrated ability to manage own workload, prioritize, plan and organize assignments and work under strict timelines is required
• Ability to follow guidelines and procedural documents Operations Sets work priorities and direction with input from Manager
• Review, extract and accurately enter AE data from ICSR reports from both investigational and postmarketing products
• Have solid working knowledge of protocol design and details relating to the extraction and entry of SAE from clinical trials reports
• Will have data review responsibility, to ensure data entries made by Safety Coordinators are accurate

Additional Information

All your information will be kept confidential according to EEO guidelines.