Case Management Senior Specialist – Global Biotech – UK (Remote) – Up to £50k
This is an exciting, global biotech at the forefront of new pharma products. Specialising in haematology, oncology, neurology and cannabinoids, this company has an exciting product pipeline in development stages, early phase and late phases stages.
- Global biotech
- Specialising in haematology, oncology, neurology and cannabinoids
- Excellent and exciting product pipeline
- Hugely supportive company, keen to develop employees to their full potential
Working as a Case Management Senior Specialist, your role will involve:
- Timely intake, reconciliation and submission of Individual Case Safety Reports (ICSRs) to and from destinations
- Regulatory Intelligence Review for ICSR Intake & Submission Requirements, and reference tracking tool maintenance
- Authoring and maintaining AE Intake and ICSR Submissions processes and standards, including AE follow-up
- Perform or oversee Serious ICSR Finalizations & Submissions
To be considered for this Case Management Senior Specialist position, my clients are looking for someone with the following profile:
- BS/BA degree in health related or biological science related field
- Knowledge of FDA and international regulations pertaining to Adverse Event and ICSR requirements, as well as ICH guidelines, including the ability to interpret and apply applicable regulations to inform decisions and resolve issues
- Experience in obtaining, analysing, disseminating, and reporting safety information in compliance with global regulations
- Experience using or familiarity with safety database applications
- Experience using MedDRA and MedDRA coding
What should you do next?
This Case Management Senior Specialist role is one not to be missed! To discuss this Case Management Senior Specialist role further or to find out about other Pharmacovigilance jobs I’m currently working on, please get in touch or hit apply to submit your current CV.
Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.