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.

Description

• 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.

Profile

• 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.

Job Offer

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.