Drug Safety Specialist Alder Biopharmaceuticals

The Drug Safety Specialist will provide technical and process-related support to clinical drug safety management, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).

This newly created position will be responsible for the following:
Triage of incoming reports for completeness, legibility and validity, including initiation of requests for follow-up as needed. Initial data entry of case reports into Alder safety database / tracking system. Assessment of case reports for seriousness, causality and expectedness. Assist in meeting Alder requirements for communication and data sharing with partners. Scheduling and chairing monthly Safety meetings, including recording and distributing minutes. Participate in project meetings / investigator meetings / project specific training sessions. Creation and maintenance of project-specific working files, case report files and project central files. Tracking trial-related documents, regulatory submissions and safety reports. Reconciliation of safety and clinical databases, including obtaining information from eCRFs and reconciliation of this data with the SAE cases. Creation of monthly Safety metrics. Assist with additional Drug Safety activities as required.

Qualifications:
Qualified candidates will have a minimum of 3 years Drug Safety experience in the biopharmaceutical setting. Degree in Nursing (RN, BSN), or other health-related field, or equivalent qualifications, sufficient for gaining extensive experience in medical terminology.. Clear understanding of drug safety / drug development process is required. Research experience in a clinical setting preferred but not required.The successful candidate will have excellent interpersonal skills and will communicate effectively with team members within the company as well as with external contacts. Strong software skills are also required, including database and presentation software.

Location:	11804 North Creek Parkway South Bothell, WA 98011 United States