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- High Wycombe, UK
- Full-time employment
- Posted on 11 Sep, 2018
- Start date:
- Visa Sponsor
Drug Safety Placement
Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of people everywhere. Career opportunities within Johnson & Johnson companies may provide you with an ideal setting to build your experience; express your passion and touch the world.
Drug safety scientists collect and evaluate information from patients and healthcare professionals to try and identify new information about the use of medicines and any side effects experienced by patients.
Safety monitoring of medicines is a continuous process, it is performed during clinical trials when medicines are developed, once medicines are launched (also called ‘licenced’) and throughout the entire period where a medicine is available for patients to use. The team is the first point of contact within the company for incoming adverse event reports. The department also monitors our pharmaceutical products across their lifecycle, from clinical trials through to post-marketing surveillance, in order to detect, assess, understand and prevent adverse events. Ultimately the team works to evaluate drug efficacy and maintain patient safety.
You will join our Pharmaceutical business in the role of a Drug Safety Scientist and will be given a high level of exposure to many aspects of the Pharmacovigilance division. This is an office-based role. This is an exciting and unique opportunity to be at the forefront of drug development in one of Europe’s fastest growing top ten pharmaceutical businesses.
Main duties and responsibilities:
- Receipt and processing of incoming safety information from multiple sources, both internal and external to the Company
- Responsible for the collection, review and reporting of Adverse Events (AEs) and pregnancy reports obtained through spontaneous reporting, solicited reports, clinical study, Local Health Authorities (LHAs) and other potential sources
- Assist with initial quality review and assessment of individual cases
- Provision of safety information/acknowledgement to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines
- Co-ordinate/perform the follow-up of missing information from the AE reporter
- Assist in the provision of local data as required supporting the preparation of Safety Summary reports (PSURs, ASR, etc.)
- Assist in the quality review of data captured in the Global Safety Database
- Ensure that day-to-day Pharmacovigilance functions are performed satisfactorily and that full regulatory compliance is maintained at the Local Operating Company (LOC) level
- Accurate and timely documentation of deviations to process/timelines. Including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs)
- Support all occurrences of internal and external audits and inspections
- Support the onboarding activities of placement student successors where possible
- Working cross-functionally with internal teams
- Collaborating with the student cohort on fundraising and charity events
Requirements of the role:
- 2 years of degree level study completed
- A minimum of 2:1 achieved in first year of study
- Bio science degree types only
Key skills and competencies:
- High level of accuracy and attention to detail
- Passion for working in the pharmaceutical industry
- Excellent communication skills both written and oral
- Seeks opportunities to learn and grow professionally
- Able to prioritise and manage own workload autonomously
- Flexible and adaptable team player
- Actively seeks feedback, appreciates and uses constructive criticism
- Bounces back quickly from mistakes; learns and moves on quickly
About Johnson & Johnson
For the past 132 years, Johnson & Johnson has been involved in defining the future of healthcare. Innovation is at our core and in 2017, we achieved record levels of investment: USD10.6 billion in R&D and USD35.2 billion in M&A. We are looking for talented individuals to lead the change that the world needs to see now— and in the years ahead—to help ensure global access to safe, viable and affordable healthcare.
With over 134,000 employees in than 60 countries, our people bring creativity, expertise, and passion to their work every day across more than 250 leading businesses in consumer products, pharmaceuticals and medical technology.
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About Johnson & Johnson
Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the live
- Health & Social Care, Science & Research, Consumer goods
- in High Wycombe, UK
- 10,000 employees
- Founded in 1886