Pharmacovigilance Scientist

4,000 professionals, 0 days wasted, 1 incredible purpose. Together, we are beating cancer. 

Pharmacovigilance Scientist x 2 - Centre for Drug Development

Salary :  £35,000 - £40,000 pa

Contract type/ hours :    Fixed term contract for 2 years/ full time 35 hours (flexible working requests considered)

Location:  Stratford, London (High flex – we’d expect you to be in the office 1 or 2 days a week) or Home -based UK.

Department: Research and Innovation

Reports to: Pharmacovigilance Manager

Application Deadline:  Wednesday 17th April at 23.55. This vacancy may close earlier if a high number of applications are received or once a suitable candidate is found, so please do not delay submitting your application to avoid any disappointment.

At Cancer Research UK, we exist to beat cancer.

We are professionals with purpose, beating cancer every day. But we need to go much further and much faster. That’s why we we’re looking for someone talented, someone innovative and ambitious, someone like you.

About the team

The Cancer Research UK Centre for Drug Development (CDD) is the world's only charity-funded drug development facility. Our pioneering research is driven purely by the goal to see scientific breakthroughs bring benefits to patients sooner.

CDD is the sponsor of early phase and precision medicine clinical trials in oncology agents. Our broad portfolio rivals that of a medium-sized pharmaceutical company, spanning antibodies, cell therapies, vaccines, drug conjugates and small molecules, making this an interesting and dynamic area to work in.

What will I be doing?

We are looking for two Pharmacovigilance (PV) Scientists to provide support for CDD clinical trials for an initial fixed term contract for 2 years. In this varied role you’ll process safety cases, including Serious Adverse Event (SAE) reports in the PV database, and report these as required according to applicable regulations. You’ll contribute to and author Development Safety Update Reports (DSURs) and assist with ongoing safety evaluations.

Key duties include:

• To be the pharmacovigilance contact on specified clinical trials sponsored by the CDD.

• Provide pharmacovigilance support to study teams, ensuring safety information is shared between PV and the study team and vice versa.

• To keep abreast of safety issues on clinical trials sponsored by the CDD.

• Prioritise and manage individual workload to ensure regulatory and business partner timelines are adhered to for the reporting of safety data.

• Assess safety cases for seriousness and expectedness and identify SUSARs.

• Enter safety cases on to the safety database as per guidelines.

• Report all SUSARs to the Competent Authorities, relevant Ethics Committees and trial Investigators within the required timelines.

• Review cases and request follow-up information when required.

• Contribute to and author DSURs as required, including writing, reviewing and submission within regulatory timelines. 

• Contribute to the ongoing safety evaluation process for the identification of safety risks.

• Assist in review of clinical trial documentation including protocols, Investigator’s Brochures and informed consent documentation.

• Provide PV support in safety data reconciliation with the clinical database.

• Maintain awareness of pharmacovigilance regulatory requirements and developments.

What skills are we looking for?

• Biological sciences degree or equivalent qualification/experience.

• Relevant experience in a Pharmacovigilance role.  

• Working knowledge of Good Clinical Practice (GCP) and applicable legislation.

• Experience entering data into a safety database, including MedDRA coding.

• Excellent planning and organisation skills.

• Excellent proofreading skills and attention to detail.

• Excellent communication skills, both written and verbal.

• Ability to maintain rigorous adherence to written procedures e.g. SOPs.

Desirable

• Experience in early-phase clinical trials.

• Oncology experience.

• Experience of writing safety reports, such as DSURs.

• Experience of study document review, such as protocols and Investigator Brochures.

What will I gain?

Each and every one of our employees contributes to our progress and is supporting our work to beat cancer. We think that’s impressive.

In return, we make sure you are supported by a generous benefits package, a wide range of career and personal development opportunities and high-quality tools, policies and processes to enable you to do your job well.

Our benefits package includes a substantial retirement plan, a generous and flexible leave allowance, discounts on anything from travel to technology, gym membership, and much more.

We review pay annually and aim to recognise individual performance and achievements. 

We don’t forget people have lives outside of work too and so we actively encourage a flexible working culture.

Our work – from funding cutting-edge research to developing public policy – will change the world. It’s exciting to be part of our team.

We operate an anonymised shortlisting process in our commitment to equality, diversity and inclusion. CVs are required for all applications; but we won’t be able to view them until we invite you for an interview. Instead, we ask you to complete the work history section of the online application form for us to be able to assess you quickly, fairly and objectively.

For more updates on our work and careers, follow us on: Linked In, Facebook, Instagram, Twitter and YouTube.

There’s a place for everyone at Cancer Research UK. Our vision is to create a charity where everyone feels like they belong, benefits from and participates in, the work we do. We're committed to creating an inclusive culture where everyone can be themselves and reach their full potential. 

We actively encourage applications from people of all backgrounds and cultures, in particular those from ethnic minority backgrounds who are currently under-represented, and believe that a diverse workforce will help us to beat cancer sooner. 

If you’re interested in applying and excited about working with us but are unsure if you have the right skills and experience we’d still love to hear from you. We don’t expect everyone to meet all of the criteria listed.

We want to see every candidate performing at their best throughout the job application process, interview process and whilst at work. We therefore ask you to inform us of any concerns you have or any adjustments you might need to enable this to happen by emailing us at . 

Unfortunately, we are unable to recruit anyone below the age of 18, so that we can protect young people from health & safety and safeguarding risks.