Drug Safety Specialist

Purpose: GENERAL SUMMARY Provide assistance in the management of all adverse event reports received, including but not limited to clinical and regulatory assessment of individual reports, preparation of reports, maintenance of electronic database, report follow-up and preparation of standard as well as ad hoc adverse event reports.


ESSENTIAL DUTIES AND RESPONSIBILITIES

Every effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform, nor is it intended to be such a listing of the skills and abilities required to do the job. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position.

1. Assess individual adverse event report for seriousness, labeling status and relatedness
2. Prepare adverse event report in the electronic safety database for review
3. Assist in the maintenance of report integrity in the electronic database
4. Maintain filing system integrity for report hardcopy
5. Follow-up adverse event reports according to SOP
6. Prepare standard and ad hoc safety reports as required
7. Assist in the maintenance of adverse event dictionary
8. Contribute to the improvement of electronic safety database and filing system
9. Establish a good working relationship with associated groups, especially clinical trials, project management, medical writing, regulatory affairs, and development/ marketing partners
10. Apply sound clinical judgment to case assessment



ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE

1. Healthcare professional, preferably a registered nurse or pharmacist
2. 1 - 3 years of pharmaceutical industry experience in drug safety and/or clinical trials
3. Basic understanding of FDA?s CFR and ICH guidelines as they pertain to adverse event reporting
4. Knowledge of and ability to work with computers and spreadsheets
5. College degree in nursing, pharmacy, health sciences or related fields with at least 3 years of relevant professional practice (preferably hospital) experienceClassification:ContractCompensation:
Based On Experience HourJoin Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries is an equal opportunity employer.

Required Qualifications:
Skills Requirements:
rn, pharmd, healthcare professional, LPN, BSNContact Information
Contact:Omelio,Vincent