FierceBiotech and FiercePharma Jobs
Clinical Safety Manager - Direct Hire Opportunity - Kelly Scientific Resources
Jan 18
Location: Seattle, WACategories: Clinical
Website: http://www.kellyscientific.com/clinical
Position Description
Kelly Clinical Research is seeking a Clinical Safety Manager for a biotechnology company in the Seattle, WA area to contribute to the preparation of new drug application (NDA) safety updates, investigational new drug (IND) safety reports, investigator communications and product labeling/package inserts. This position will work on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors and the ability to exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Summary of Responsibilities:
• Will participate in oversight of ongoing clinical trials and in the preparation of new drug applications with respect to drug safety which may include one or more of the following:
Manages the company’s clinical safety process.
Manages the company’s pharmacovigilance process.
Manages compliance with standard operating procedures.
Develops reports for company management as well as external regulatory agencies.
*Contributes to the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications and product labeling/package inserts.
• Will facilitate a multidisciplinary safety committee, which will review select individual serious adverse event (SAE) cases and aggregate adverse event (AE) data for trends, as well as signal detection summaries from all studies.
• Will facilitate and coordinate Independent Data Monitoring Committees. Will prepare presentations, maintain communication as specified in the charters and promptly respond to issues.
• Will interface with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements.
• Will provide technical expertise to other departments as part of cross-functional project teams.
• Will contribute to the development of department budget.
• Will select, develop and evaluate personnel to ensure functional objectives are met.
Job Requirements:
• Bachelor’s degree as RN/BSN, RPh/PharmD or equivalent.
• 7 years related experience in cGMP/FDA regulated industry.
• 3 years leadership / supervisory experience.
• Some exposure with MedDRA and ArisG is preferred.
• Proficient in MS Office applications.
• Additional and incidental duties as required
If you meet the above qualifications and would like to be considered for this opportunity, please forward your resume to jaegesu@kellyservices.com
