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  • Job type

    Contract
  • Location

    Maidenhead
  • Working Pattern

    Full-time
  • Specialism

    Drug Safety And Pharmacovigilance
  • Industry

    Pharmaceuticals
  • Pay

    Hourly Rate
  • Closing date

    30 Apr 2024

Quality Document Manager - Safety Surveillance and Aggregate Reports - 12-month Contract - Pharmaceutical

Your new company
My client, a global pharmaceutical and biotech company with a goal of contributing to healthcare innovation and environmental sustainability. They are focused on improving people’s quality of life by preventing, alleviating, and curing diseases. They have a wide pharmaceutical portfolio, specialised in some of the following areas: Oncology, neuroscience, and rare diseases. There is an opportunity for a Quality Document Manager to join their Safety Surveillance and Aggregate Reports team on a 12-month rolling contract.

Inside IR35
Onsite 2/3 days per week


Your new role
As a highly motivated individual, you will join their Safety Surveillance and Aggregate Reports team as an Associate Quality Document Manager, where you will perform QC review to ensure documents authored by the Safety Surveillance and Aggregate Reports (SSA) team or their vendors are of high quality. Also, support process improvement and other SSA functions, for example, vendor management, SharePoint management.


What you'll need to succeed
You will hold a bachelor’s degree in biologic or natural science, or health care discipline. Advanced degree (PhD, MPH, NP, PharmD, etc.) is preferred.
You will possess good writing and editing experience within the pharmaceutical or biotech industry.
You will be familiar with pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts.
You will have the ability to understand, interpret, analyse, and clearly present scientific and medical data in verbal and written format.
You will have the ability to interact collaboratively and effectively in a team environment.
You will possess strong organisational skills, including the ability to prioritise independently.
You will be proficient and comfortable using Microsoft Office (in particular, Word, Excel, and PowerPoint), SharePoint platforms and be familiar with Documentum-based systems and common safety database systems.

What you need to do now
Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and residing in the UK.
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on 03330106292
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.

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