The Prinicipal Safety Systems Analyst (PV Systems Analyst) supports the development and maintenance of key systems supporting the Pharmacovigilance business unit. The primary focus is the Argus Safety System databases.
The support provided is from a business perspective and includes such activities as the preparation and maintenance of user guides and training materials, development of custom Argus Safety Systems reports, as well as ad-hoc listing and maintenance of select business configuration in Argus and participation in user requirement definitions and user acceptance testing. Essential Duties and Responsibilities include the following. Other duties may be assigned.
Education and/or Experience:
- Provide overall guidance and thought-leadership on use of standard Argus front-end reporting; including use of advanced conditions
- Maintains systems configuration documentation
- Configures and runs Safety Database reports
- Develop and document standard and ad hoc reports from the safety database
- Create front end advanced conditions including query sets and generate custom reports from the Argus database.
- onduct routine and ad hoc data extraction (i.e. PSURs, DSURs, 6-monthly listings)
- Ensure that search algorithms are clearly and consistently documented
- Support and educate to end users and sponsors, if applicable
- Maintain and document system configuration of the Argus Safety system based on initial requirements and any subsequent changes
- Receive and respond to Argus Safety system user questions/issues
- Conduct project specific configurations
- Inspect and resolve safety database problems quickly and effectively
- Collaborate with Project team to determine scope, goals and objectives
- Other duties assigned by management
Essential Skills and Abilities:
- BA/BS in life science or equivalent
- Four years of experience in risk management and/or Pharmacovigilance
- Working knowledge of Oracle PL/SQL
- Experience with safety database (e.g., Argus) business support and/or maintenance and/or training experience highly desirable
- Experience with use of ad-hoc database query tools
- Working knowledge of Pharmacovigilance regulations and guidance
- Intermediate analytical skills
- Excellent written and verbal communication skills
- Good organizational and time management skills
- Working knowledge of MedDRA
- Ability to establish sound working relationships with people globally, in various functions with a wide variety disciplines and backgrounds
- Ability to accept responsibility and be pro-active within defined limits
location: Tarrytown, New York
job type: Permanent
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.