At STADA we pursue our purpose “Caring for people‘s health as a trusted partner” worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals. More than 12,300 employees around the globe live our values Integrity, Entrepreneurship, Agility and One STADA to achieve ambitious goals and shape the successful future of STADA.

Britannia Pharmaceuticals, part of the STADA Arzneimittel AG group of companies, is a UK based pharmaceutical company specialising in the neurology market. Britannia focuses on innovative products for chronic and serious medical conditions, and in particular, the treatment of Parkinson’s disease. We are highly committed to improving the quality of life for People with Parkinson's disease.

PV Intern   

Reading | United Kingdom (GB) | Full-time | Fix-term 

OBJECTIVE

To perform PV activities in line with relevant MHRA/EU regulations, directives and guidelines

KEY ACCOUNTABILITIES

• Using the Global Safety Database to perform case processing for Britannia and Thornton & Ross products

• Perform PV follow-up reminders

• Perform reconciliation of safety data

• Perform administrative tasks for the Denzapine Monitoring Service (DMS) e.g. Diluents/reagents orders, printing/ posting blood labels, entry of blood results, changes to patient profile (Patient/Pharmacy/Collection Centre/Consultant), processing rejected blood samples, patient transfers (in and out), patient de-registrations

• Set up of team meetings and writing minutes

• Updating PV agreements with updated product and contact information

• Processing DMS Registrations (DMS website users, Prescriber, Pharmacy, Patient)

• Processing DMS Blood Results (including identifying adverse events)

• Answering the DMS phone line

• Identifying and processing DMS Off-label requests, Special Monitoring Parameter Requests, Treatment Breaks, Patient Re-challenges

• Compiling compliance metrics

Company compliance with MHRA/EU PV regulations, directives and guidelines

Is responsible for working in accordance with Britannia internal compliance procedures, legislation, and regulatory requirements at all times.  This includes, but not limited to, directives and guidance such as PMCPA, NMC, APBI Code of Practice, GMDP, GVP and other GxPs

PERSONAL SPECIFICATION (Skills required to perform the job)

• Excellent multi-channel communication skills and the ability to adapt these to all levels of internal and external customers

• Exceptional organisational skills

• Good interpersonal skills – ability to work with cross-functional teams

• Computer literate with knowledge of all MS packages

• Accuracy and attention to detail

• Ability to work under pressure

• Ability to work under own initiative – proactive problem-solving approach

we are regrettably unable to accept applications from candidates who do not have the right to work in the UK or require a sponsorship to work in the UK.

Are you looking for new challenges where you can make a difference for people’s health? We are looking for candidates with positive attitude, expert knowledge and an entrepreneurial spirit that enjoy friendly working environment in a global team. We would be pleased to get to know you. Please use our online job portal to submit your application: https://jobs.stada.com