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Drug Safety Specialist

Seattle Genetics, Inc.

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Location: Bothell, WA Posted Date: 4/29/2013 Position Type: Full time Job Code: 1304LK-01 Required Education: High school or equivalent

Description

Reporting to the Manager, Case Management, the Drug Safety Specialist has the primary responsibility for the preparation and timely submission of all safety reports, including expedited safety reports. Additional duties and responsibilities include:

•   Receive, process, evaluate (from a regulatory standpoint) and report investigational and marketed safety information (e.g., adverse events, pregnancy reports, overdose reports) in compliance with applicable domestic and international regulations and guidelines as well as Drug Safety’s Standard Procedures (SOPs, Training Aid, Training Guides).
•   Perform the initial medical review of AE/SAEs including assessment of drug-relatedness and expectedness and coding of the events using MedDRA dictionary
•   Perform accurate data entry of identified safety information into the safety database including the writing of concise narratives.
•   Directly, or through clinical personnel, conduct follow-up with reporters/clinical sites to obtain all pertinent adverse event information
•   Perform the initial medical review of AE/SAEs including assessment of drug-relatedness and expectedness, coding of the events using MedDRA dictionary and the writing of concise narratives
•   Manage the completion, routing and approval of SAE reporting documentation
•   Submission of SAE reports to pertinent regulatory agencies (in conjunction with Regulatory Affairs)
•   Distribution of SAE reports to clinical sites (in conjunction with Clinical Operations)
•   Manage CRO personnel working on Seattle Genetics’ Drug Safety’s behalf
•   Author / Review new processes (SOPs, Training Guides/ Aides) as necessary to support the Drug Safety Department
•   Assist in establishing Database standards to support Drug Safety
•   Coordinate and facilitate the weekly review of SAEs with Medical personnel and/or clinical teams to assure timely assessment of all cases
•   Act as the safety liaison /resource on clinical study teams for safety related issues relating to all clinical development of Seattle Genetics’ compounds
•   Assist with the preparation of safety-related sections and associated documentation for clinical and regulatory documents (e.g. clinical study protocols and clinical study reports)
•   Work with Biometrics/Data Management to assure SAE reconciliation and develop adverse event coding procedures to assure consistent AE MedDRA coding
•   Mentor more Junior Drug Safety Specialist as applicable.

Requirements

•   Demonstrated knowledge of domestic and international regulatory safety reporting requirements. Must have excellent, concise writing skills
•   Experience with the use of drug safety databases (e.g., Argus, ARISg, etc.)
•   BS Pharmacy, PharmD, BS RN degree with critical care management background preferred, MD or equivalent training
•   Three years experience in Drug Safety in a biopharmaceutical environment is preferred.

Seattle Genetics is an equal opportunity employer.
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