• This role offers an excellent opportunity for professional growth
• Joining this company will allow you to contribute to impactful project

Sobre o nosso cliente

Our client is a global healthcare company committed to improving access to high-quality medicines and healthcare solutions worldwide. With a strong international presence, the company plays a key role in delivering innovative and reliable healthcare solutions to patients and healthcare professionals across diverse markets. The Senior Specialist, xEVMPD/IDMP will be responsible for the coordination and compilation of regulatory documentation for xEVMPD/IDMP submissions to various Health Authorities. Contribution to regulatory systems project to assure business needs are met and optimized for efficiency and effectiveness. Tracking on registration activities and status to deliver on-demand reports that meet internal business needs and regulatory authority requirements.

Descrição

• Monitor the Veeva RIM system for submissions that require xEVMPD reporting;
• Communicate with Regulatory Leads and Third Party companies to obtain all information required to complete the xEVMPD submissions in a timely manner;
• Maintain xEVMPD (Article 57) relevant data utilizing Veeva RIM and submit data to Health Authorities, while ensuring data quality and compliance with submission timelines;
• Assist with generation of reports and reconciliation of xEVMPD data with Regulatory Leads and Affiliates as required;
• Assist with responses to Health Authority questions related to xEVMPD data as required;
• Assist with the Annual PV Fee Advice Note review with the EEA Affiliates, ensuring that corrective actions have been implemented in the xEVMPD database as instructed by the Affiliates;
• Maintain proficiency with xEVMPD/IDMP related business processes, Veeva RIM software and Health Authority requirements;
• Work in conjunction with the Learning and Development team to provide subject matter expertise to support the creation of training and educational material;
• Provide input into the creation of Standard Operating Procedures, Work Instructions and Job Aides as appropriate for relevant business processes and systems;
• Support the Regulatory Operations Systems Support team to suggest, review and implement changes to existing business tools and systems;
• Collaborate as a member of internal project teams to identify and resolve issues while developing opportunities to reduce inefficiencies through new and/or improved IT solutions, business processes or tools;
• Perform other duties as assigned consistent with the grade of the role.

Perfil ideal

• Bachelor's degree or equivalent experience in Life Sciences, Scientific Affairs, Information Management, Business Administration, or a related field;
• Minimum of 4 years of experience within the pharmaceutical industry, Regulatory Operations, Regulatory Affairs, or Regulatory Data Management;
• Strong experience with xEVMPD and/or IDMP processes and regulatory data management;
• Experience with xEVMPD/IDMP software and related data management tools (e.g. Veeva) is strongly preferred;
• Experience with Veeva RIM or similar Regulatory Information Management systems;
• Familiarity with document management systems such as Veeva Vault, D2, or equivalent platforms;
• Strong attention to detail with a focus on data quality and compliance;
• Ability to manage multiple priorities and deadlines in a fast-paced, cross-functional environment;
• Excellent communication, analytical, and problem-solving skills;
• Proficiency in spoken and written English is required.

Vantagens

The company offers a competitive compensation and benefits package, as well as the opportunity to work in a collaborative, international, and cross-functional environment that values diversity, inclusion, and professional growth.