IT Business Analyst Regulatory Affairs & PV (JR003370) Uppsala, Sweden
We are looking for an IT Business Analyst Regulatory Affairs & PV with expertise in both Information Technology and Regulatory Affairs/Pharmacovigilance. The IT Business Analyst Regulatory Affairs & PV will act as a bridge between senior stakeholders and the IT team. He/She will translate business needs into a functioning set of systems and hardware that will improve Galderma’s Regulatory Affairs & Pharmacovigilance systems and overall business performance.
Responsibilities include but are not limited to:
Change Activities
- Integration of new solutions to existing systems
- Master data governance implementation
- Monthly Change Advisory Board meetings to drive evolutions/enhancements to the systems
- System life cycle management (investment strategy, upgrade roadmap, decommissioning
- Establishment of the sustain governance model around the systems
- Business partnership with user representatives to align our service level and activities with business expectations
- Support audits and inspections from regulatory authorities
Project Related Activities
- Plans, organizes and coordinates activities, participate to project plan and resources monitoring (new solutions deployments, upgrades, new regulations)
- Plan, prepare and moderate specifications workshops with business stakeholders in order to translate business requirements/wishes into Specifications
- Assess and execute on new regulatory requirement impact on systems
- Ensure compliance to Data Privacy regulations
Consultant Management
- Be the primary contact from IT for any task executed by external consultants, such as design change request, interface or report setup.
Budget and Procurement
- Comply with purchasing policies, Ensure Purchase Order in place with external consultants
- Ensures sustain costs are included in appropriate budgets, participate to cost tracking versus budget
To ensure success in this role you will have:
- 5 years in IT organization/pharma industry
- Knowledge of GxP and Pharma regulations, Regulatory Affairs/ Operations process and Pharmcovigilance process
- Experience (project management or daily use) with all or some of the following systems: Documentum, D2, RIM solutions (Calyx, ArisG), Argus, Signal Detection,ISI toolbox, EURS Validator
- Scrum expertise is a plus
- Fluency in English is a required, professional proficiency in French or Swedish a plus
- Degree in Computer Science or Information Systems or Life Sciences