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• Support Operations Team Associates with administrative duties as assigned
• Generate follow-up letters based on verbatim questions
• Archive cases according to corporate processes
• Perform quality control (QC) of source documents

Key Responsibilities:

• Adverse Event Case Management

• Acting as a point of contact for receipt and collection of initial and follow-up Adverse Event (AE)/device reports via e-mail, fax, post, and phone or in person
• Communicating AE/device information to Global Patient Safety (GPS) Regional Centre
• Conducting follow-up as directed or required
• Filing of case source documentation.

• Provide Administrative Support for the UK Affiliate Activities

• Filing adverse event case files and associated documentation, regulatory authority acknowledgement communication, and all other Drug Safety documentation
• Archive Drug Safety documentation to e-archive and retrieve Drug Safety documentation from the e-archive when necessary
• Proactively provide administrative support for the Operations Team Associates
• Identify opportunities to enhance and improve the Operations Team related administrative tasks
• Confirm receipt of any Adverse Event reports received (where appropriate)
• Support the team with other pharmacovigilance activities, as required
• Perform and organise QC as needed for projects
• Support with Third Party Organization (TPO) reconciliation activities.

• Provide Back up for General Administrative Support

• Manage the Outlook calendars
• Coordinate meetings, including teleconferences and videoconferences
• Prepare letters, memos, email messages, minutes, agendas, and so forth
• Perform general duties such as faxing documents, photocopying, maintaining files, archiving and sorting/distributing mail.

• Cross functional operational support

• Submit Literature attachments to Regulatory Agencies as required
• Perform QC of Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) messages before submissions to the database
• Perform QC of Ethical Review Boards daily Individual Case Safety Report (ICSR) data preparation
• Provide Ethics Review Board (ERB) and Development Safety Update Report (DSUR) submission support as needed for Ethics Review Boards and National Competent Agencies.

• Regulatory Compliance and Asset Protection

• Be compliant with policies, procedures, and regulations for managing adverse events data
• Understand the confidential nature of company information and take necessary steps to ensure its protection
• Review, understand and comply with Lilly asset protection policies and procedures.

• Training and Development

• Develop knowledge of adverse event process and compliance requirements
• Have a general understanding of the roles and responsibilities of the European Union Qualified Person for Pharmacovigilance (QPPV)
• Understand local and global regulations that may impact the process
• Mentor and coach less experienced staff.

• Quality

• Strive for inspection and audit readiness and participate in affiliate inspections, audits, and assessments
• Maintain, review, and update local Standard Operating Procedures (SOPs) in a timely manner ensuring alignment with the global GPS documentation and local regulations
• Provide SOP training when applicable
• Document post-data entry quality check for accuracy of all AE information communicated to GPS Regional Centre against source documentation
• Communicate issues and propose process improvements during team meetings and to management.

• Effective communication skills (verbal and written) to interact with diverse groups and individuals
• Proficient in Microsoft Office Suite
• Knowledge of copier and fax machines
• Confidentiality
• Ability to manage multiple tasks simultaneously
• Attention to detail and organisational skills
• Adherence to regulatory requirements relevant to job tasks
• Working knowledge of corporate policies, workplace guidelines.

• Minimum: Education to GCSE level with Maths and English at Grades A-C or equivalent
• Preferred: GCSE in Science, Biology or Chemistry or similar discipline at Grades A-C.

• Communication Skills
• Creativity
• Self-Management Skills
• Maturity in Judgement
• Interpersonal/Teamwork Skills
• Knowledge of Medical Terminology