Product Safety Administrator

Our Client is a very successful pharmaceutical company. They are now seeking a Product Safety Administrator. This position is a full-time permanent role and will be office based near Hitchin in Hertfordshire.

Job Purpose

• The successful candidate will join a small, friendly, Pharmacovigilance (PVG) team, reporting to the Senior PVG Executive, to provide comprehensive administrative support.
• The team is responsible for managing customer feedback concerning safety and quality issues involving healthcare products. This particularly includes helping to make sure all such feedback is reported, collected, investigated, escalated accordingly and, where appropriate, remedied.
• All of this must be performed following strict regulatory requirements in a timely manner.

Key Areas of Responsibility

• You will be required to help ensure all customer feedback involving Product Safety or quality issues is collected and processed appropriately by the Pharmacovigilance team. 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
• You will perform a leading role in entering and checking customer feedback information from all sources into the company’s computerised database. As well as ensuring cases are progressed through the various workflows necessary for their investigation, formal reporting, and resolution by relevant colleagues. You will be involved in all administrative tasks requiring timely correspondence with complainants to foster customer goodwill and conciliation
• You will be responsible for the activities required to maintain a bibliographic database of published scientific reports relevant to the safety evaluation of products. This includes responsibility for weekly searches, obtaining reprints, categorizing them, and adding them to the database
• When required, you will prepare summary reports necessary for purposes of monitoring and trending Product Safety issues. Additionally, the role will involve implementing and continually improving the Product Safety monitoring processes in accordance with evolving regulatory requirements and the company’s Quality Management System. You will be responsible for assigned controlled documents (e.g., Standard Operating Procedures and work instructions) to ensure they are kept up to date and valid.

Qualifications / Experience

• To be considered for the position, you will need to be able to demonstrate excellent written and verbal communication skills as well as good organisational skills
• You will also need to have strong planning skills with computer competence and meticulous attention to detail. You will need to be able to prioritise and manage your own workload.
• An understanding of pharmacovigilance requirements or medical knowledge would also be an advantage

In return our client is offering a competitive basic salary plus comprehensive benefits for the successful Candidate

Please send your C.V to Lorraine Roger, Director at Atom Recruitment Ltd.