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Drug Safety Specialist
Seattle, WA 98101 United States
The Drug Safety Specialist is responsible for all aspects of adverse event processing and reporting for assigned investigational products, while maintaining compliance with Acucela SOPs and FDA, ICH, and worldwide regulations to ensure uniform and timely processing and reporting of adverse event reports. This individual may serve as a liaison to external investigational sites and company personnel for safety-related issues, working in close collaboration with colleagues from Clinical Operations, Regulatory Affairs, Quality and Medical Affairs. The scope of this position requires medical knowledge and the ability to work independently and prioritize workload, with experience in all phases of clinical development.
Key Accountabilities/Core Job Responsibilities:
• Assess initial and follow-up adverse event reports for regulatory reporting requirements.
• Contact investigators or coordinators to solicit comprehensive information about reported adverse events as well as relevant follow-up information.
• Enter cases into the safety database, write case summaries, and perform the initial analysis of similar events.
• Code all adverse event terminology, other medical information, and drug information in safety database using MedDRA and WHO-DDE dictionaries, in accordance with Acucela coding conventions.
• Document communications with contacts to obtain follow up information.
• Participate in writing safety sections of clinical protocols, informed consent documents, and CRFs.
• Prepare material for, and coordinate inter-departmental Safety Review Teams and/or Data Monitoring Committees.
• Support reconciliation between clinical trial and safety databases.
• Query database to obtain data for ad hoc and submission of annual reports.
• Manage assigned projects and responsibilities in accordance with obligations and commitments established in SOP’s and contractual agreements.
• Assist in the oversight of CRO and business partners to ensure adherence to safety management plans and data exchange agreements.
• Represent DSS on clinical, pre-clinical and scientific project teams, as requested
• Assist with compiling and/or authoring pharmacovigilance agreements between Acucela and business partners
• Support internal and/or business partner audits and/or regulatory inspections.
Education, training, experience:
• Minimum Bachelor’s level degree in life sciences, pharmacy, or nursing. RN or PharmD strongly preferred.
• Minimum of 3 years clinical experience in the pharmaceutical/biotechnology industry to include a minimum of one year clinical drug safety experience.
• Excellent working knowledge safety database software applications. Safety database system administration experience is a plus.
• Ability to organize and integrate complicated and often incomplete data from a variety of sources using good documentation practices and complying with all applicable safety regulations.
• Excellent written, verbal, organizational, and interpersonal skills.
• Comprehensive knowledge and understanding of local and international safety reporting regulation, applicable regulatory guidance(s) and industry best working practices.
• Self-motivated, adaptable to change, attentive to detail, able to function independently and as a team member.
• Enthusiastic, efficient, persuasive and goal driven.
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