S & P Specialist

Technical Resources International, Inc.; Bethesda (MD); Hybrid; USD 70.000 - 85.000; Vollzeit

Zusammenfassung

A healthcare consulting company is seeking a S & P Specialist based in Bethesda, MD. This full-time role requires conducting compliance checks, evaluating adverse event reports, and supporting clinical research. Candidates should have a Master's Degree and 2+ years of relevant experience. The position offers a hybrid work model, combining office work with remote days. If you are passionate about drug safety and regulatory compliance, this role may be a perfect fit.

Qualifikationen

• 2+ years of academic, pharmaceutical or biotech industry experience is required.
• Knowledge of safety databases and/or MedDRA coding preferred.
• Must have excellent computer skills.

Aufgaben

• Ensure compliance with regulatory standards for reporting adverse events.
• Develop and process adverse event reports uniformly and timely.
• Provide medical evaluation of adverse event reports.

Kenntnisse

Knowledge of GCP and ICH guidelines

Excellent oral, written, and presentation skills

Experience leading clinical teams

Ausbildung

Master's Degree

Jobbeschreibung

Job Title

S & P Specialist

Location

Bethesda, MD 20817 US (Primary)

Category

Drug Safety

Job Type

Full-Time

Salary Range

70,000.00-85,000.00/YEAR

Education

Master's Degree

Travel

None

Job Description

• Ensures compliance with TRI Standard Operating Procedures, Food and Drug Administration and World Health Organization regulations and global regulations for the reporting of adverse events to regulatory agencies
• Develops and ensures the uniform and timely processing of adverse event reports
• Provides medical evaluation of adverse event reports
• Performs various tasks in support of clinical research including the reporting, collecting, and sharing of results and issues around adverse event reports both for currently marketed drugs as well as those in the experimental stages of development
• Maintains/updates agent-specific clinical and preclinical toxicity study summary tables for investigational agents
• Performs literature searches
• Performs various tasks in support of clinical research including adverse event analysis and processing, serious adverse event reconciliation
• Preparation of IND safety reports for submission to the FDA; safety document or data analysis
• Clinical trial site support; reporting, collecting, and sharing of results and issues around adverse event reports both for currently marketed drugs as well as those in the experimental stages of development
• Assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communication, product labeling/package inserts, and other reports as necessary
• May review experimental protocols and informed consent documents; and prepare, review, and edit presentations regarding safety issues

Job Requirements

• Knowledge of GCP and ICH guidelines preferred; drug development/clinical trial experience essential
• Knowledge of safety databases and/or MedDRA coding preferred
• Experience leading clinical and cross functional teams is a plus
• Must have excellent oral, written, presentation and computer skills
• 2+ years of academic, pharmaceutical or biotech industry or academic experience
• This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.