Clinical Safety Data Management Associate

Seeking expert execution in Configuration/Change Management/Ad-Hoc Data Requests/Aggregate Data Tables for the Safety Information Management (SIM) system portfolio.

Incumbent will partner with Business Technology and other business stakeholders to ensure ARGUS Configuration or Change Management/ad-hoc Data Requests/Aggregate Data Tables are fulfilled with data integrity according to defined requirements and timelines.

RESPONSIBILITIES:

- Supports utilization of Information Management (IM) systems and processes by responding promptly to end-user inquiries
- Investigates solutions to operations' issues and develops or contributes to written materials that communicate solutions and/or options to relevant stakeholders resulting in appropriate decisions.
- Liaises with business stakeholders and technical groups to define or gather business requirements, define new or improve business processes.
- Participate in developing and performing User Acceptance Testing (UAT) as required
- Lead small projects of short duration following established methodologies
- Liaise with business stakeholders and technical groups to provide/review impact assessments of business requirements and technical change which include the identification of processes and applications, required changes to these processes and applications, and alternatives to mitigate impact.
- Maintain a collaborative program of continuous improvement within the organization.
- Complete training in accordance with Safety information Management curriculum. {s}

SKILLS

REQUIRED SKILLS & QUALIFICATIONS:

- Minimum of 3 years or relevant experience in data management with clinical safety data and business processes in the pharmaceutical industry, including an understanding of the drug development process.
- Experience with query tools/data extraction techniques (eg, SQL, PL/SQL, Brio, MS Access)
- Knowledge of Safety, Regulatory, and/or Document management systems and technologies
- Experience with relational databases
- Knowledge of application system management and change control processes, application validation and implementation in a GxP environment
- Knowledge of Pharmaceutical metadata and standards
- Bachelor's Degree/equivalent employment experience in life sciences, or information management related discipline required.
- Knowledge of FDA, EMEA and ICH regulations is preferred.
- Demonstrated customer relationship skills and capabilities and collaboration on teams.
- Demonstrated ability to perform in a cross-functional environment.
- Strong verbal, written communication and presentation skills.

DESIRED SKILLS & QUALIFICATIONS:

- ARGUS Administrator experience is highly desirable.

Synectics is an Equal Opportunity Employer.