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Senior Safety Systems Analyst

Acorda Therapeutics

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Location: Ardsley, NY Posted Date: 4/8/2013 Position Type: Full time Job Code: Senior Safety Systems Analyst Required Education: Bachelors Degree Areas of Expertise Desired: Bioinformatics
Drug Safety

Description

The Safety Systems Analyst is responsible for providing Argus based systems support for Acorda Drug Safety and Risk Management activities including data collection, data analysis, report generation, and submission tracking.

*Essential Duties and Responsibilities include the following. Other duties may be assigned.
Supports the generation of complete and accurate periodic regulatory reports and ad-hoc reports, for various constituencies with in interest in the safety database i.e. Operations, Legal, Clinical and Risk Management. Develops Argus system training under direction of the head of safety systems. Participates in the establishment of Data Entry Guidelines to ensure consistent and accurate data entry. Assists in the configuration and validation of safety system updates and upgrades. Represents safety systems on the Argus Project Team; ensures all validation documentation needs are met to auditable standards. This includes validation plans, flow charts, system design specifications, user requirements, trace matrix and test scripts Assists with the testing, validation and execution of E2B certification. Maintains and adheres to Periodic Report schedule, creating aggregate submissions in submission ready standards (PSURs, PADERs, ASRs and DSURs). Contributes to the development of validated Post marketing and Clinical Signal Detection Reports. Manages change controls, upgrades. Documents the Safety Database System Configuration. Applies configuration and workflow setup to system. Develops and executes test scripts to verify compliance to system configuration. Provides Argus Safety user support, user training, and system administration. Develops safety system training materials and delivers training to employees. Participates in the establishment of Data Entry Guidelines to ensure consistent and accurate data entry.

Requirements

Education and/or Experience:
Bachelor's degree in computer science, bioinformatics or related field required. Minimum of five years of previous experience in Systems Management or Safety Data Management. Prior experience in the pharmaceutical or biotechnology industries is required.

Supervisory Responsibilities: None

Qualifications:
Strong knowledge of pharmacovigilance terminology and system data entry conventions. Broad knowledge of relevant ICH guidelines, as well as FDA and EU Regulations preferred. Demonstrated technical, analytical and problem solving skills as it pertains to safety database systems preferred.

Computer Skills:
Must be Proficient in MS Office Suite. Broad knowledge of Pharmacovigilance Database (e.g. ARISg, Argus). Minimum of two years programming experience with SQL or sufficient demonstrated proficiency required. Experience with E2B software (Axway Synchrony (Cyclone), Bizconnect) preferred. Familiarity with reporting tools such as Spotfire, Cognos, or Business Objects is preferred.

Certificates, Licenses, Registrations: none required

Other Skills and Abilities:
Excellent written and verbal communication skills. Must demonstrate a keen attention to detail and timelines. Ability to manage both day-to-day operations as well as project work in a fast paced environment. Ability to work both independently and in a collaborative team setting. Ability to interpret and follow regulatory guidelines.

Physical Demands:
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
There is minimal travel for this position; the average travel is 5-10% with some variation based upon the demands of the business imperatives.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
No specific work demands.

*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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