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Duration : 12 months

Location : High Wycombe, Buckinghamshire

Sector : Pharmaceuticals

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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:

• 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.

Qualifications

Requirements of the role:

• 2 years of degree level study completed

• A minimum of 2:1 achieved in first year of study

• 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

• Self-motivated

• Actively seeks feedback, appreciates, and uses constructive criticism

• 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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