Top 2 Elisa Jobs in Dallas Tx

drug safety and pharmacovigilance
Sally Health & Innovative Partners —Dallas, TX
- $150,000 - $200,000 a year
- Full-time
- Hybrid work
- Doctoral degree
- Senior level
- Health insurance
- Dental insurance
Quick Apply
Chemist II
BIOCHROMA ANALYTICAL LABS —Dallas, TX
- Full-time
- Mid-level

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drug safety and pharmacovigilance

Sally Health & Innovative Partners
Dallas, TX

Quick Apply

Job Details

Full-time
$150,000 - $200,000 a year

Benefits

Health insurance
Dental insurance
401(k)
Flexible spending account
Tuition reimbursement
Employee assistance program
Vision insurance
401(k) matching
Employee discount
Professional development assistance
Flexible schedule
Life insurance
Referral program

Qualifications

Immunological assays
Cell line culture
Biochemistry
Teamwork
Doctoral degree
Pharmacovigilance research
GxP
Team leadership
Immunological laboratory techniques
R
Flow cytometers
Pre-clinical study projects
ICH guidelines
Biochemical laboratory techniques
Product development
Clinical program data analysis
Managing clinical research teams
Biomedical regulatory compliance
In vivo studies
Clinical quality assurance standards
Pre-clinical studies in drug product development
Regulatory compliance analysis
Cross-functional collaboration
Clinical data analysis
Pharmaceutical research experience
Cytometry
Technical Proficiency
Cross-functional communication
Leading research teams
FDA regulations

Full Job Description

Overview
Join our dynamic team as a Drug Safety and Pharmacovigilance Specialist, where you'll play a pivotal role in ensuring the safe and effective use of pharmaceutical products. This position offers an exciting opportunity to contribute to the monitoring, assessment, and management of drug safety data across clinical and pre-clinical phases. Your expertise will help uphold the highest standards of pharmaceutical regulatory compliance while supporting innovative drug development initiatives. Be part of a forward-thinking organization committed to advancing healthcare through meticulous safety surveillance and research excellence.

Duties

Monitor and evaluate adverse event reports, ensuring timely and accurate documentation in compliance with FDA regulations and international pharmacovigilance standards.
Conduct detailed data analysis using statistical tools such as R, MATLAB, and other software to identify safety signals and trends within clinical trial data.
Collaborate cross-functionally with clinical research teams, toxicology units, and regulatory affairs to integrate safety data into overall drug development strategies.
Develop and review safety-related documents including risk management plans, periodic safety update reports (PSURs), and investigator brochures.
Oversee pharmacovigilance activities during all phases of clinical trials, ensuring adherence to Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) guidelines.
Assist in assay development, tissue culture experiments, and in vivo studies related to drug safety assessments, including animal tissue sampling and animal drug administration.
Maintain comprehensive records of safety data, ensuring compliance with pharmaceutical regulatory requirements and internal quality standards.

Requirements

Proven laboratory experience with tissue culture techniques, mammalian cell culture, ELISA assays, Western blotting, flow cytometry, and molecular biology methods.
Strong understanding of FDA regulations related to drug safety monitoring and pharmacovigilance practices.
Certification in ICH GCP (International Conference on Harmonisation Good Clinical Practice) from a recognized issuer for CA or equivalent certification.
Proficiency in statistical analysis for research using R, MATLAB, or similar software; experience with data interpretation is essential.
Hands-on experience with in vivo studies including animal tissue sampling, animal drug administration, pharmacokinetics, toxicology research, and pre-clinical studies in drug product development.
Knowledge of pharmaceutical research processes such as assay development, experimental design, clinical research methodologies, and clinical trials management.
Familiarity with GLP standards, FDA regulations governing clinical development phases, and pharmaceutical regulatory compliance requirements.
Demonstrated ability to lead teams effectively within a research setting while fostering collaboration across multidisciplinary functions.
Strong background in biochemistry, biotechnology, toxicology research, statistics, and laboratory techniques relevant to pharmacovigilance activities.
Technical proficiency with laboratory instruments such as flow cytometers and Western blot apparatus; experience with AI applications in data analysis is a plus.

Embark on a rewarding career that combines scientific rigor with impactful healthcare innovation! We are dedicated to supporting your professional growth through ongoing training opportunities while fostering an inclusive environment where your expertise makes a real difference in patient safety worldwide.

Pay: $150,000.00 - $200,000.00 per year

Benefits:

401(k)
401(k) matching
Dental insurance
Employee assistance program
Employee discount
Flexible schedule
Flexible spending account
Health insurance
Life insurance
Professional development assistance
Referral program
Tuition reimbursement
Vision insurance

Education:

Doctorate (Required)

Work Location: Hybrid remote in Dallas, TX 75201

Quick Apply

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elisa jobs in dallas tx

drug safety and pharmacovigilance

Chemist II

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