PHARMACOVIGILANCE OFFICER

Company background:

ROKC is a Clinical Research Organisation specialising in the design, management and delivery of global multi-centre clinical trials of investigational medicines, and post authorisation observational/cohort/efficacy and safety studies. Working in partnership with the largest infectious disease clinical networks in Europe together with pharmaceutical and bio-technology clients, our focus is primarily in Infectious diseases, including HIV and COVID-19.

We are seeking to appoint an ambitious Pharmacovigilance Officer, with a minimum of 3 years’ experience, ready to take the next step in their career and contribute to the growth and development of our business operations in the UK and Europe. The successful applicant will have a variety of duties relevant to the successful delivery of our diverse portfolio of Clinical Projects:


Responsibilities:

  • Monitor drug safety inbox and manage (collect, track, process, and query) SAE/SUSAR reports and follows-up

  • Checking the accuracy and quality of all reports in relation to clinical study protocol, GCP and Clinical Trials legislation, requesting additional information where necessary, and processing these within strict timelines

  • Conduct expedited safety reporting using MHRA Submissions platform, Eudravigilance etc 

  • Generate and submit CIOMS reports

  • Liaise with staff members regarding PV quality control activities and conduct

  • Ensure all aspects of the local pharmacovigilance system are maintained in accordance with company SOPs

  • Keep abreast of the national/international pharmacovigilance requirements

  • Interacts with internal departments associated with safety related information

  • Carry out PV specific Protocol/Patient facing material review/QC as needed

  • Prepares and maintain Pharmacovigilance Management Plans for all projects

  • Overview of all tasks and communications with clients

  • Update of PV activity tracking databases 

  • Prepare DSURs according to SOPs and their submissions to authorities

  • Coordinate the ROKC Medical Monitoring Panel members and activities

  • Author educational and support materials relating to PV activities in general and on specific studies where required

  • Coordinate and conduct company internal PV orientation training programme on project specific PV activity-related procedures, general PV education and important updates

  • Monitor compliance results and propose corrective and preventive actions. Preparation of Deviation reports.

  • Ensure compliance with applicable local guidelines and regulation

  • Maintain and establish of quality standards for local pharmacovigilance activities

  • Participate in inspection and/or audits

Requirements:

  • Life science degree

  • Experience working within pharmacovigilance from a clinical trials perspective

  • Minimum 3 years’ experience in Pharmacovigilance

  • Comprehensive understanding of current pharmacovigilance legislation and ability to effectively implement them

  • Experience with safety databases, MedDRA coding, EudraVigilance, XEVMPD

  • Fluent spoken and written English language is essential

  • Excellent communicator with the ability to build relationships and liaise with people at all levels. 

  • Strong computer literacy (MS Office), experience with PV databases

  • Strong organisational and time management skills

  • Ability to work independently and in a team

  • Applicants must be eligible to work in the United Kingdom

 

Our Offer:

  • Competitive salary £40,000 to £50,000 (commensurate with experience)

  • Full time permanent position with 25 days Annual Leave

  • Professional training and career development

  • Contributory Pension Scheme

  • Private Healthcare Cover

  • Flexible remote working arrangements

  • Laptop and Mobile phone provided

 

Please note this is a permanent role and we cannot consider agency submissions or freelancers

 

To apply please upload a copy of your CV and contact details