Drug Safety Specialist
Hays

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

An American Company is seeking a Drug Safety Specialist in Bethesda, MD.

Role Description

• 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
• Prepares, reviews, and edits presentations regarding safety issues

Skills & Requirements

M.D. or D.O. from an accredited institution or RN, PhD, PharmD, or MPH with direct Drug Safety experience, Infectious disease and/or oncology subspecialty highly preferred; knowledge of GCP and ICH guidelines preferred; drug development/clinical trial experience essential; knowledge of CTC 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 pharmaceutical or biotech industry or academic experience.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

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Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570

Drug testing may be required; please contact a recruiter for more information. #1143024