Job Description
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.
Company Description
Beacon Hill Life Sciences, a part of BHSG, a specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations.
Beacon Hill Life Sciences places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Life Sciences National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.
Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Life Sciences matches world class talent with exceptional opportunities.
Company Description
Beacon Hill Life Sciences, a part of BHSG, a specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations.\r\n\r\nBeacon Hill Life Sciences places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Life Sciences National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.\r\n\r\nWhether start-ups or the Fortune 500, the public or private sector, Beacon Hill Life Sciences matches world class talent with exceptional opportunities.