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

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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

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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

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