Job Description

Duration : 12 months

Location : High Wycombe, Buckinghamshire

Sector : Pharmaceuticals

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For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in the UK are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means \xe2\x80\x9cYou Belong\xe2\x80\x9d!

Position summary:

IPV Case Management Specialists 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 \'licensed\') 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 IPV Case Management Specialist and will be given a high level of exposure to many aspects of the Pharmacovigilance division. This is an office-based role with global reach working with colleagues from around the world. 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:

\xc2\xb7 Working in collaboration with teams across the globe to ensure the safety of our medicines

\xc2\xb7 Work on global initiatives/projects to support the safety organisation

\xc2\xb7 Become an integral part of the team to ensure the goals and compliance of the safety organisation are met.

\xc2\xb7 Receipt, assessment and processing of incoming safety information from multiple sources and countries, both internal and external to the Company

\xc2\xb7 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

\xc2\xb7 Assist with initial quality review and assessment of individual cases

\xc2\xb7 Provision of safety information/acknowledgement to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines

\xc2\xb7 Co-ordinate/perform the follow-up of missing information from the AE reporter

\xc2\xb7 Working with colleagues from around the world on multiple projects, developing strong project management and leadership skills

\xc2\xb7 Assist in the provision of local data as required supporting the preparation of Safety Summary reports (PSURs, ASR, etc.)

\xc2\xb7 Assist in the quality review of data captured in the Global Safety Database

\xc2\xb7 Ensure that day-to-day Pharmacovigilance functions are performed satisfactorily, and that full regulatory compliance is maintained at the Local Operating Company (LOC) level

\xc2\xb7 Accurate and timely documentation of deviations to process/timelines. Including root cause analysis and documentation of Corrective and Preventive Actions (CAPAs)

\xc2\xb7 Support all occurrences of internal and external audits and inspections

\xc2\xb7 Support the onboarding activities of placement student successors

\xc2\xb7 Collaborating with the student cohort on fundraising and charity events

\xc2\xb7 Contribute to maximizing vendor support and vendor oversight

\xc2\xb7 Support in utilising technology solutions to reduce manual tasks.

Qualifications

Requirements of the role:

\xc2\xb7 2 years of degree level study completed

\xc2\xb7 A minimum of 2:1 achieved in first year of study

\xc2\xb7 Science degree types only

Key skills and competencies:

\xc2\xb7 High level of accuracy and attention to detail

\xc2\xb7 Passion for working in the pharmaceutical industry

\xc2\xb7 Excellent communication skills both written and oral

\xc2\xb7 Seeks opportunities to learn and grow professionally

\xc2\xb7 Able to prioritise and manage own workload autonomously

\xc2\xb7 Flexible and adaptable team player

\xc2\xb7 Self-motivated

\xc2\xb7 Actively seeks feedback, appreciates, and uses constructive criticism

\xc2\xb7 Bounces back quickly from mistakes; learns and moves on quickly

Please note that we plan to close for first round of applications on 7th October, but could close earlier if we receive too many applications.

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