What are the responsibilities and job description for the Regulatory Affairs Coordinator position at ProPharma Group?
Job Description
We are looking for a Regulatory Affairs Coordinator to join our team at the ProPharma Group. As a key member of our team, you will be responsible for daily case processing of adverse event cases (clinical trial and/or post-marketed) including coding using MedDRA.
In this role, you will perform case follow-up activities such as identifying information to be collected during follow-up, creating and reviewing case narratives, and providing client notifications as required for case management.
You will also support and contribute to the development of training materials and training delivery, highlight areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing when related to ICSRs, and acquire and maintain an up-to-date knowledge of global safety regulations for medicines.
Responsibilities
- Daily case processing of adverse event cases (clinical trial and/or post-marketed)
- Case follow-up activities such as identifying information to be collected during follow-up
- Creating and reviewing case narratives
- Providing client notifications as required for case management
- Supporting and contributing to the development of training materials and training delivery
- Highlighting areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing when related to ICSRs
- Acquiring and maintaining an up-to-date knowledge of global safety regulations for medicines
Qualifications
- Strong verbal, written, and interpersonal communication skills
- A high level of accuracy and attention to detail
- An ability to identify and resolve problems in a timely manner
- The ability to work independently and collaboratively in a multi-disciplinary team
- Excellent organization and prioritization skills; able to multitask
- A basic knowledge of Pharmacovigilance
