Safety Associate - Pharma - database queries - Code:jmartin

Title of Position: Safety Associates
Interview Schedule: Personal Interview, Horsham, PA

Qualifications:
The Safety Analyst is responsible for logging and tracking of requests for database or query support; generation of listings and reports for: ad-hoc query requests, in support of Aggregate Reporting, in support of surveillance and signaling. Additional responsibilities include performing data quality checks along with writing and performing user acceptance tests for system enhancements and modifications. Also responsible for working with Local Case Reporting users to troubleshoot problems with cases to ensure regulatory compliance
Will make decisions regarding: Priority of incoming requests (except legal and regulatory requests)Search strategies for simple and complex queries Daily prioritization of assigned work and team workload Priority and assignment of regulatory or legal requests
The Safety Analyst is responsible for logging and tracking of requests for database or query support; generation of listings and reports for: ad-hoc query requests, in support of Aggregate Reporting, in support of surveillance and signaling. Additional responsibilities include performing data quality checks along with writing and performing user acceptance tests for system enhancements and modifications. Also responsible for working with Local Case Reporting users to troubleshoot problems with cases to ensure regulatory compliance

Day-to-Day Responsibilities:
Perform ad-hoc and standard searches, create related documentation 25%
Log and track incoming requests 25%
Perform system administration tasks 15%
Perform data quality checks 10%
Trouble shoot errors with Local Case Reporting and E2B 10%
Other Tasks as Assigned 10%
Perform User Acceptance Testing  5%
Develop and maintain procedures and guidelines  5%
Assigned workload and day to day work assignments
Resolve 1st level technical problems and issues
Defer 2nd level and network issues to appropriate support group
Work with team lead to prioritize daily work
Describe the Technical Environment:

Overview of Company Culture:
One of the positions will be located in Morris Plains, NJ and the other two will be located in Horsham PA. All in person interviews will be in Horsham PA. And please note that for the Morris Plains person, they need to know in advance that they will have to spend the first 6 weeks in Horsham for training.
BS Computer Science, Statistics or Life Sciences (or related experience) preferred. Pharmaceutical Industry experience preferred.
Ability to prioritize
Strong working knowledge of relational databases
Clear and concise documentation skills
Demonstrated knowledge of current SOPs / SWPs
Practical knowledge of safety regulations preferred
Intermediate to advanced skills in Microsoft Excel preferred
Attention to detail
Positive attitude
Strong written and oral communication skills
Time management skills and ability to work in strict timelines
Strong interpersonal skills

Category:	Biotech/Pharmaceutical
	> Safety      > Quality Assurance/Quality Control      > Regulatory Affairs      > Document Control      > Research & Development
Location:	Horsham, PA
County:	Montgomery County
ZIP Code:	19044
Pay Rate:	Open
Job Terms:	full time
Company:	APEX Systems, Inc.
Phone:	email only
Fax:	email only