Job Description

SAFETY & PHARMACOVIGILENCE SPECIALIST

Contract to perm

Hybrid in Bethesda

RESPONSIBILITIES

• Ensures compliance with 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.

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.

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser:

Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser:

• Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records. "

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