Pharmacovigilance Regulatory Submission Specialist

Introduction

We are currently recruiting a Pharmacovigilance Regulatory Submissions Specialist to join a leading blue chip company in Cambridgeshire.

Important

Previous experience of working in a pharmacovigilance team

The Job

In this role you will be responsible for the submission of expedited safety reports to the regulatory authority, ethics committees, investigators. You will also be responsible for reviewing and interpreting regulatory legislation for safety reporting requirements.

Skills and experience required include:
* Previous PVG/drug safety experience is essential within a pharmaceutical, clinical or healthcare setting
* Safety database experience
* Strong knowledge of safety departmental procedural documents
* Working knowledge of applicable FDA regulations and guidelines
* Good Microsoft Word and Excel skills; basic understanding of database functionality
* Ability to identify and set priorities and effectively perform a variety of tasks simultaneously, including those with set deadlines
* Strong attention to detail and accuracy with orientation toward careful and meticulous work
* Ability to maintain a positive attitude
* Ability to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members, and other internal staff members
* Ability to work effectively within a team to attain a shared goal
* Demonstrates initiative and completes assigned tasks with limited supervision
* Ability to maintain focus while working within strict timelines

To apply for this position, candidates must be eligible to live and work in the UK