LMS Case Management Specialist

3 days ago

High Wycombe, United Kingdom Disability Solutions Full time
Johnson & Johnson is currently seeking a Placement Student to join our Local Medical Safety team located in High Wycombe.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

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 "You Belong"

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Position summary:

LMS 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 LMS 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.

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Main duties and responsibilities:
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  • Working in collaboration with teams across the globe to ensure the safety of our medicines
  • Work on global initiatives/projects to support the safety organisation
  • Become an integral part of the team to ensure the goals and compliance of the safety organisation are met.
  • Receipt, assessment and processing of incoming safety information from multiple sources and countries, 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
  • Working with colleagues from around the world on multiple projects, developing strong project management and leadership skills
  • 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
  • Collaborating with the student cohort on fundraising and charity events
  • Contribute to maximizing vendor support and vendor oversight
  • Support in utilising technology solutions to reduce manual tasks.
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