Pharmacovigilance and Regulatory Administrator

An opportunity has arisen for a Pharmacovigilance and Regulatory Administrator to join the Clinical and Regulatory Affairs department, Monday to Friday, 9am to 5pm.

The role will provide comprehensive and broad-ranging administrative support to our teams responsible for managing customer feedback concerning safety and quality issues involving our healthcare products and managing Medical Device documentation.

The key responsibility will be to ensure all customer feedback involving product safety or quality issues is collected, recorded, and responded to in a timely manner. This involves effective liaison with customers, internal functions such as Sales and Marketing, Clinical Research, Quality Assurance, Queries Handling / Medical Information, Regulatory Affairs, telephone receptionists / mail room staff and external business partners such as distributors, companies employed to collect customer feedback and marketing partners.

Additional tasks will include (but are not limited to):

• Taking ownership of activities related to the maintenance of our bibliographic database and assigned controlled documents (e.g. SOPs or work instructions).
• Preparation of data for reports used for the monitoring and trending of safety issues in relation to our products.
• Review of documents including regulatory standards, specification and guidelines, and completing gap analyses to assess the impact of any changes.
• Review and approval of artwork documents.
• Conducting regulatory reviews on production documents prior to product manufacture.

Key Attributes/Skills:

The successful candidate will have excellent verbal and written communication skills, with the ability to prioritise, and manage their workload effectively. They will be competent in the use of Word, Excel and other Microsoft applications, and ideally have experience in the use of databases. They will also need to have strong organisation and planning skills with computer competence and meticulous attention to detail.

Experience in Pharmacovigilance or Regulatory Affairs is preferred but not essential.