As a key member of the Pharmacovigilance Information and Systems (PVIS) group, the Business Systems Associate contributes in all aspects to the department’s success. The PVIS group has overall responsibilities for business owned safety systems activities, in particular enabling the exchange of individual case safety reports according to international and local reporting requirements, to Drug Safety Affiliates, health authorities and licensing partners. Other responsibilities include evaluating and implementing technology enhancements to support business processes, maintenance of the business configuration of the systems, as well as implementing and maintaining standard reports.
The Business Systems Associate leverages a combination of business and technical knowledge to contribute to the development, implementation and integration of Drug Safety’s business strategies, processes and solutions.
Focus of this position is on the support and administration of the system. Supporting key processes to ensure efficient maintenance of the business configuration of the system.
Principle functional responsibilities:
- Provides change management, master data maintenance (i.e. business configuration via user interface) and front-line application support for applicable drug safety systems on behalf of PDS
- Interacts with drug safety functional groups, other information management functions in development, IT organizations, external business partners, vendors and health authorities
- Reviews business requirements, specifications and process documentation
- Participates in global, cross-functional activities and projects, i.e. within PDS, as well as affiliates and other PD functions
- Maintenance of the systems’ Master Data (i.e. business configuration via user interface) such as user account management, regulatory reporting rules, document templates, protocols, drug dictionaries
- Assumes responsibility for development and maintenance of the PDS Roche Intranet presence
- Provides support, administration and change management for existing Drug Safety systems
- Acts as a process owner for Master Data activities and works closely with the management team to ensure that the process remains effective and works efficiently
- Support preparation, delivery and maintenance training overview of all new starters as part of Global PDS Induction Programme
- Performs and documents user acceptance testing on submission rules and associated processes
- Ability to interpret business and regulatory reporting requirements to enable system users to comply with current guidelines and plan for future changes
- Works closely with colleagues to identify and implement technology solutions to meet business requirements
- Drug safety knowledge or other relevant experience in the drug development environment within the pharmaceutical industry
- Knowledge of drug safety regulatory obligations and guidelines
- Knowledge of medical terminologies, e.g. MedDRA
- Computer literacy
- Fluent in English
- Personal Attributes:
- Able to take ownership of assigned processes
- Proactive approach to work
- Displays a high level of commitment
- Works well in a team environment
- Good attention to detail
- Ability to work under pressure
- Ability to evaluate data and draw conclusions independently
- Confident decision maker
- Proven good communication skills
- Good time management and organisational skills
- Able to multitask
- Structured/ methodical approach to work
Qualifications and experience requirements
- Currently undertaking a life science / pharmacy qualification
Accepted degree subjects
Welwyn Garden City
How to apply
Please ensure you include a CV and cover letter with your application. As part of your cover letter, Roche is keen to understand your motivation in applying for this position. You should, therefore, provide responses to the following questions:
- What is your key motivation for applying for this placement?
- What skills and experience will you bring to the role?
- What personal qualities will you bring to the role?
- What skills or abilities do you expect to develop through this role?
- What interests and activities do you have outside work and study?
Your cover letter should not exceed one page.
Closing date: Continuous recruitment
This job listing will no longer be available on Prospects from 31/08/2018