Drug Safety Administration Coordinator

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The purpose of the role of the Operations Team Assistant, United Kingdom (UK) Affiliate is to:

- 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

An assistant’s responsibilities can vary depending on the needs and focus of the team as well as the experience of the individual

Key Responsibilities:

- Adverse Event Case Management
- 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
- 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.

Education requirements:

- 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.

Other additional preferences:

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