Global Safety Data Management
Global Safety Data Management
Reporting to the VP, Head of Global Drug Safety, this position will be responsible for ensuring the satisfaction of Global Drug Safety (DS) needs for the successful implementation of systems and standardized processes in the support of DS. This position will ensure that systems and processes fulfill the desired compliance, business process, data integrity, quality, security and system governance objectives globally.
Leading the effort of selection and implementation of Drug Safety solutions to ensure a robust, efficient, scalable, cost-effective, and “best in class” DSsolutions.
Satisfactory implementations and management of changes to DS systems. Act as the primary business contact for IT for requirement development, design, implementation and validation of systems, as needed.
Responsible and accountable for day-to-day management of vendors engaged in support and implementation of DS systems.
Responsible for development, implementation and oversight of processes and procedures relating to effective management of global systems with the objective of maintaining their validated state. This includes providing metrics measuring the efficiency and effectiveness of the team.
Responsible and accountable for timely escalation of issues and concerns that impact the DS business, collaboration and efficient working of the team to the Global Head of DS.
Responsible for financial tracking against approved budget.
Work in a highly collaborative manner with all DS team members to understand their needs and translate them into prioritized plans for action.
Negotiate and oversee all DS systems vendor service agreements.
Work effectively with Genmab internal and external stakeholders on cross-functional projects on behalf of DS.
Communicate regularly with management and all users of information services and systems
Skills & Experience
Bachelor’s degree in life sciences or related field required. Master’s degree preferred.
At least 5-8 years direct experience supporting successful global Safety databases, data migration and/or implementations for large or medium-sized Pharma. Experience must include reviewing business process and requirements analyses with a strong focus on ensuring customer satisfaction.
Demonstrated knowledge and experience in implementing solutions to meet global DS/Pharmacovigilance regulatory requirements especially in the EU US, and Japan.
Demonstrated ability to manage multiple concurrent projects.
Demonstrated 5 to 8 years strong project management knowledge and experience.
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