Drug Safety Analyst
Job Description
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title: Drug Safety Analyst
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
Description:
We are seeking a Drug Safety Analyst to support global pharmacovigilance operations for both investigational and marketed products. This role plays a critical part in ensuring high-quality safety data, regulatory compliance, and timely reporting.
This position is ideal for candidates with strong experience in safety data analysis, pharmacovigilance systems, and database reporting, particularly those who have worked with safety databases and reporting tools in regulated environments.
Key Responsibilities
Safety Data Analysis & Reporting
Pharmacovigilance Database & Systems
Compliance & Regulatory Support
Additional Responsibilities
Required Qualifications
Critical Skills & Experience (Highly Preferred)
Technical & Regulatory Expertise
What We’re Looking For
Why Apply?
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you shortly.
You may also send your resume and cover letter via email to the recruiter listed below. You MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!
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Title: Drug Safety Analyst
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: 1+ year contract, extension or conversion possible
- Pay rate: $42 - $45.70/hr
- Job Location: Los Angeles, CA
- Schedule: M-F, 8am – 4:30pm
- Job#: bh18783
Description:
We are seeking a Drug Safety Analyst to support global pharmacovigilance operations for both investigational and marketed products. This role plays a critical part in ensuring high-quality safety data, regulatory compliance, and timely reporting.
This position is ideal for candidates with strong experience in safety data analysis, pharmacovigilance systems, and database reporting, particularly those who have worked with safety databases and reporting tools in regulated environments.
Safety Data Analysis & Reporting
- Analyze and process safety data to support aggregate reports and regulatory submissions
- Develop and execute data extraction queries for pharmacovigilance documentation
- Perform database queries to identify interval and cumulative cases for periodic reports
- Generate case listings for regulatory and business needs
- Support signal detection and signal management activities
Pharmacovigilance Database & Systems
- Maintain data consistency and integrity within the global safety database
- Support database configuration updates, including:
- Regulatory submission rules
- Product and study configurations
- Partner with IT to support system validation, testing, and enhancements
- Contribute to continuous system improvements and process optimization
Compliance & Regulatory Support
- Ensure compliance with global pharmacovigilance regulations and reporting timelines
- Support audits, inspections, and CAPA activities
- Collaborate with Regulatory Affairs on aggregate safety reporting requirements
- Maintain and support PV documentation (SOPs, WPs, specifications, process flows)
Additional Responsibilities
- Review scientific literature and support medical safety assessments
- Develop training materials and support internal knowledge sharing
- Assist with change management and implementation of new systems/processes
- Bachelor’s degree in Health Sciences, Life Sciences, or Information Technology
- 2+ years of pharmacovigilance experience
- 2+ years of safety database or data management experience
- Strong experience with safety data analysis and reporting tools (Business Objects strongly preferred)
- Hands-on experience with:
- Data extraction queries and reporting
- Database querying for safety case analysis
- Ensuring data integrity within safety systems
- Experience supporting database configuration updates tied to regulatory submissions
- Proficiency in Microsoft Office (Excel, PowerPoint, Visio, Word)
- Experience in GMP environments and/or computer system validation (CSV) (essential)
- Knowledge of E2B (R2) and E2B (R3) standards (preferred)
- Familiarity with:
- MedDRA
- WHO Drug Dictionary
- Medical terminology
- Strong analytical and problem-solving skills
- Ability to work independently and manage multiple priorities
- Detail-oriented with a focus on data accuracy and compliance
- Effective communicator with cross-functional collaboration experience
- Opportunity to support global pharmacovigilance initiatives
- High-impact role focused on data integrity, compliance, and patient safety
- Flexible work arrangement (hybrid/remote potential)
- Long-term contract with competitive pay
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you shortly.
You may also send your resume and cover letter via email to the recruiter listed below. You MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!
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Meet Your Recruiter
Caroline Driscoll
Account Manager & Sr. Technical Recruiter
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