Senior Drug Safety Specialist
The Drug Safety Specialist (DSS) is involved in daily case management for serious adverse events (SAEs) reported from clinical trials. The DSS attends monthly project meetings as well as weekly department meetings. During 2008 there will be several projects related to process improvement and the DSS will be involved. These projects may require extended hours beyond 40 hours a week.
The DSS has the following responsibilities:
- Processes SAE reports from clinical studies
- Provides drug information about investigational products to internal/external customers
- Supports Sr. DSS with safety surveillance activities and interactions with business partners and CROs
- Assists with the preparation of BLA/NDA and IND reports, investigator communications, product labeling/package inserts, and other reports as necessary
- Conducts literature and database searches
- Collaborates with internal departments to support and develop standard operating procedures/working practices
- Adhere to corporate and departmental standard operating procedures
Requirements
- BS in pharmacy or nursing, PharmD, PA
- Minimum of 2 years of drug safety/pharmacovigilance experience, premarketing safety preferable
- Excellent written and verbal communication skills; ability to write concise descriptive case narratives
- Knowledge of FDA/EMEA regulations regarding safety
- Experience with adverse event software (eg ARISg) and drug information is highly desirable.
Required Skills for Senior Drug Safety Specialist Job:
- SAE
- GCP/ICH
- SOP
- CLINICAL RESEARCH
- DRUG SAFETY
Join 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 are equal opportunity employers.
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