Drug Safety Associate (08-77)

Synteract is a full-service contract research organization (CRO), dedicated to meeting the various clinical development needs of the biotechnology, medical device, and pharmaceutical industries. We have provided clinical trial services on several hundred studies on over 40,000 patients to over 80 commercial clients, including all phases and across a wide range of therapeutic areas, such as oncology, cardiovascular, ophthalmology, CNS, and virology. We are located atop the beautiful flower fields of Carlsbad, in North San Diego County.DescriptionYou will receive and analyze Serious Adverse Event (SAE) information for completeness, accuracy and regulatory reportability requirements; evaluate SAE case data with an emphasis on medical presentation, conduct discussions regarding specific patient case data with health care practitioners and Sponsors; determine regulatory reporting requirements based upon case data, product information, and FDA or ICH guidelines and regulations; prepare SAE Reports, including preparation of narrative summary; identify missing/discrepant data, write queries, address queries with site personnel, evaluate query responses, and resolve queries when complete. Additionally, you will maintain the SAE database and perform coding of adverse event terms and concomitant medications.Required SkillsQualified candidates will have a Bachelor's degree in nursing (B.S.N.), Registered Nurse (R.N.), or Doctor of Pharmacy and 3+ years’ relevant experience.Required ExperienceRequires in-depth knowledge of medical terminology and of GCPs, ICH guidelines and FDA regulations with an emphasis on safety. Must possess a professional demeanor; demonstrate initiative, sense of urgency, ability to organize and prioritize, and keen attention to detail.Join our multi-talented team! At Synteract you will find professional growth, talented colleagues, competitive salaries and solid benefits. Our employees thrive because they continuously grow, learn and collaborate.We do work hard, but we enjoy a balance between work and play. We offer flexible work schedules, alternative work weeks, and telecommuting opportunities to afford that balance. If that is what you are in search of, perhaps this is the place for you. Please apply directly at: http://hostedjobs.openhire.com/epostings/jobs/submit.cfm?fuseaction=dspjob&jobid=188355&company_id=15957&jobboardid=24