Pv Intern

2 weeks ago


Reading, United Kingdom STADA Arzneimittel AG Full time

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**Fantastic Internship opportunities, here at Britannia Pharmaceuticals**
- We have a hybrid working arrangement in place as standard for office-based colleagues. Please consider that you would be required to travel to the Reading office 3 days a week, on a **Monday**, **Tuesday **and **Thursday** before applying**.** You must be able to provide proof of right to work in the UK.- Application Deadline on 19/04/2024_
- Assessment Centre Held on 08/05/2024_

**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
- 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

**VALUES** - **Actively embraces and positively demonstrates Company Values- **Integrity** - Each and every one of us acts ethically in line with the company's internal and external standards. Our actions are led by speaking up and respect
- **Entrepreneurship** - Each and every one of us drives new ideas and actions, creating future growth and value
- **Agility** - Each and every one of us leads change with flexibility and decisiveness as part of our ongoing journey of personal development
- **One STADA** - Each and every one of us acts in the best interests of the company as a whole rather than our business unit or function in order to build one successful STADA

**CORE COMPETENCIES**

**Personal Excellence**
- Continually producing high quality work which meets the company standards
- Manages own daily activity and actively adapts to changing priorities, business demands

**Delivering Results**
- Identifies mistakes and takes action to correct
- Takes ownership of own work and accepts responsibility for impact in own and others’ areas

**Relationship Building and Communication**
- Actively listens and correctly interprets messages, understands assignment instructions and applies them as directed and seeks clarity and guidance when required**SPECIAL RELATIONSHIPS AND CONTACTS (Internal and External)**
- All internal stakeholders
- To liaise effectively with colleagues locally, internationally and with third parties (Healthcare Professionals, Consumers, Licensing Partners, Consultants) regarding DMS and PV matters
- Plus any other tasks reasonably requested and deemed appropriate by the company. The above points (key accountabilities) should be carried out in accordance with company policy and to a professional/high standard, taking account of commercial and legal requirements as well as e



  • Reading, Reading, United Kingdom CSL Seqirus Full time

    The Manager, Global Aggregate Reports Quality and Compliance is an integral member of the Global Aggregate Report office and PV Writing Organization.The position holder responsibility includes the entire CSL product portfolio and development pipeline.Responsibilities include: -Acts as a Regulatory Intelligence Triage Manager, responsible for driving initial...


  • Reading, United Kingdom CSL Seqirus Full time

    The Manager, Global Aggregate Reports Quality and Compliance is an integral member of the Global Aggregate Report office and PV Writing Organization.  The position holder responsibility includes the entire CSL product portfolio and development pipeline.Responsibilities include: -Acts as a Regulatory Intelligence Triage Manager, responsible for driving...


  • Reading, Berkshire, United Kingdom CSL Seqirus Full time

    The Manager, Global Aggregate Reports Quality and Compliance is an integral member of the Global Aggregate Report office and PV Writing Organization. The position holder responsibility includes the entire CSL product portfolio and development pipeline. Responsibilities include: - Acts as a Regulatory Intelligence Triage Manager, responsible for driving...

  • Planner

    7 days ago


    Reading, United Kingdom Orion Full time

    Job description Key Accountabilities and Responsibilities: - Prepare, execute, and manage daily planning activities. - Proactively communicate supply status and conduct critical analytical analysis to identify and resolve issues. - Develop fully coordinated baseline EPC Level 3/4 schedules and Level 2 Schedules to support proposals. - Collect information...