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Validation Engineer
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CSV/ Validation Engineer
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safety & pharmacovigilence specialist - Cambridge, United States - Beacon Hill
Description
SAFETY & PHARMACOVIGILENCE SPECIALIST
Candidate must be currently located in the DMV area
6 month temp to hire
Location - Cambridge, MA (hybrid schedule)
Medical experience and drug safety experience is Required
Pharm D, Nursing MD or DO
RESPONSIBILITIES
• perform 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
REQUIREMENTS
• M.D. or D.O from an accredited institution
• Infectious disease and/or oncology subspecialty highly preferred
• Must have knowledge of GCP and ICH guidelines
• 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
• 3+ years of 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."