US-MD: Rockville-Drug Safety Specialist

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Job Title: Drug Safety Specialist
Job Location: MD: Rockville
Pay Rate: Open
Job Length: full time
Start Date: 2008-03-22

Company Name: Human Genome Sciences
Contact: HR
Phone: email only please
Fax: email only please

Description: Drug Safety Specialist

Location Rockville, MD

Job ID 2507 Employment Status Full-Time Regular

Required Experience 2-5 years

Required Education Bachelors Degree or Equivalent

Required Travel No

Relocation Available No



Summary/Description Human Genome Sciences (HGS)is located in the Washington, DC metro area, and was founded in 1992 with the goal of creating a global biopharmaceutical company to discover, develop, manufacture, and market gene-based drugs to address unmet medical needs. We have a significant product pipeline with seven products in clinical development, including drugs to treat hepatitis C, lupus and other autoimmune diseases, anthrax exposure, and cancer. In recent years, we have progressed toward becoming a late stage development and commercialization company, and we have recently started Phase 3 trials for three of our key development programs. HGS is developing an innovative new treatment for systemic lupus erythematosus (SLE), which would be the first new treatment for lupus in nearly 40 years. This product, belimumab, is being co-developed and commercialized with Glaxo SmithKline. We are also developing a long-acting interferon alpha, Albuferon, for Hepatitis C, along with Novartis. HGS has also been awarded a two-phase contract with US government to supply them with ABthrax, a monoclonal antibody treatment for anthrax, for the Strategic National Stockpile, which we expect to deliver in 2008. At HGS, people are the key to our success. We share a passion for scientific and business innovation, creating unique opportunities to contribute to the commercialization phase of our products. At HGS, you will have opportunities to learn and grow, interacting with talent of the highest caliber, and you will be supported by a culture committed to employee and leadership development. We offer a competitive salary and benefits package. HGS is an Equal Opportunity Employer EOE/AA M/F/D/V Please visit www.hgsi.com for further information on our company and to apply on-line for this position.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.




Please refer to Job code hgs-9092 when responding to this ad.


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