Drug Safety Specialist (12-months contract)

17 Jul 2019
31 Jul 2019
R & D
Full Time
Experienced (non-manager)
Drug Safety Specialist (12-months contract)

This is a fantastic opportunity to apply for this Drug Safety Specialist (DSS) 12-months contract position.

The role of a DSS requires demonstrable competence in the role and provides the opportunity to develop your career further in Drug Safety. If this is you, please read on.

Reporting to one of the Drug Safety Managers, you will be responsible for maximising the quality of information captured relating to all UK adverse events and ensuring this is recorded and submitted accurately and in a timely fashion according to local/ global SOPs and related documents. Clear and accurate data capture is required to process cases efficiently and in compliance with reporting requirements and timelines.

You will follow up cases appropriately and respond to queries politely and within timelines. Any issues will be escalated appropriately and followed up until resolution. You will participate in workload discussions with the UK Drug Safety Centre team to determine successful management of all required task and support the department in ensuring high standards are maintained and opportunities for departmental improvements are identified and implemented.

In addition the DSS:
  • Provides assistance and advice to Internal and External customers (e.g. Medical Information, Regulatory, Clinical Colleagues and other team members) on incoming Adverse Events, data capture/assessment and submission issues.
  • Provides assistance and advice to Internal and External customers (e.g. Business Operations, Strategic Insights & Analysis and external service providers) on Market Research and Patient Support Program pharmacovigilance requirements.
  • Assumes the leadership and/or contributes to projects relating to departmental processes. Works proactively and independently with minimal supervision on such projects. Keeps Drug Safety Managers regularly updated on progress.
  • Understands the reporting requirements for the MHRA and submits reports correctly and in a timely manner.
  • Involved in Quality checking various safety activities including data entry.
  • Reviews and writes controlled documents for assigned processes as appropriate.
  • Provides Adverse Event Training to Welwyn site and external vendors when necessary.
  • When requested by Drug Safety Managers, supports team during audits/ regulatory inspections.

To be successful in this role, you will be a qualified pharmacist or hold a relevant nursing qualification, life sciences degree or relevant experience in Drug Safety. You will be computer literate with the ability to accurately collect and input data and work to timelines in compliance with SOPs and Regulations.

Knowledge of Drug Safety regulatory obligations and medical terminology is required with solid business process understanding and knowledge of the pharmaceutical industry (Drug Development, Medical Affairs).

Previous experience of the pharmacovigilance arena is required.

If you are proud of contributing and feel you have the commitment to teamwork and innovation that we are seeking, then Roche is the organisation for you.  In return we offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation, including a genuine interest in your development and progression. 

To be considered for this position, please apply using the link below.

When completing your application, please ensure you attach an up to date CV and details of your current remuneration package.

The next step is yours. To apply today, click on the "Apply online" button below

Roche is an equal opportunity employer.
Research & Development, Research & Development > Drug Safety