We are looking for a highly motivated individual to join our team as our Senior Drug Safety Specialist/Manager, Drug Safety.

MAJOR DUTIES & RESPONSIBILITIES:
Reporting to the Associate Director or Director of Drug Safety, this position has the primary responsibility for the preparation and timely submission of all safety reports, including expedited safety reports.

For assigned studies: manage and implement the collection, preparation and reporting of serious adverse events (SAEs) for all in-house and/or CRO or partnered studies to include :
- Initial capture of all event-related information
- Directly, or through clinical personnel, conduct follow-up with clinical sites to obtain all pertinent adverse event information
- Perform the initial medical review of 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
- Filing of SAE reports to pertinent regulatory agencies (in conjunction with Regulatory Affairs)
- Distribution of SAE reports to clinical sites (in conjunction with Clinical Operations)
- Assist with the maintenance and /implementation of an SAE/safety database and modify as necessary (with additional support from Biometrics/Clinical/IT)
- Support the Pharmacovigilance Committee with tables summarizing adverse events, SAEs, and narratives of particular events (in conjunction with Biometrics)
- 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 study project 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 (i.e. clinical study protocols, clinical study final reports, IND annual reports, integrated summaries of safety etc…)
- Work with Biometrics/Data Management to assure AE/SAE reconciliation and develop adverse event coding procedures to assure consistent AE MedDRA coding
- Develop processes to assure updated MedDRA versioning both within Drug Safety and Biometrics to assure that requirements for individual safety report submissions are met