Description
The Drug Safety Associate will be responsible for:- Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.
- Review, rank, verify, process and document: event terms; case classifications (validity, seriousness) special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly.
- Review case criteria to determine the appropriate workflow for case processing.
- Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
- Write and edit the case narrative.
- Determine and perform appropriate case follow-up, generating follow-up letters
- Liaise with key partners, locally , and other stakeholders regarding safety data collection and data reconciliation
- Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database
- Determine reportability of scheduled reports , ensuring adherence to regulatory requirements
- Consistently apply regulatory requirements and Company policies
Minimum requirements:
- A BSc is essential.
- Experience and skill with medical writing an advantage
- Ability, with supervision, to solve routine problems and to surface issues constructively
- Ability to make basic decisions with an understanding of the consequences
- Experience in Pharmacovigilance, and with the Argus Safety database, is essential
- Demonstrated computer literacy, particularly in the use and management of relational databases
- Ability to work under supervision in a matrix organization
If you have previous experience in Drug Safety within a Pharmaceutical company or Clinical research organisation please email me with your interest and availability.