- Mentor new recruits to ensure timely and accurate ICSR processing.
- Assist with the processing of case (Spontaneous, literature and clinical) as required in compliance with applicable regulations and Quanticate SOPs, and as requested by the Pharmacovigilance Scientist or above. Prepare case narratives as appropriate.
- Triage of cases for completeness, accuracy and redaction, determining expectedness against the reference safety information and appropriateness for expedited reporting.
- Prepare and submit case notifications to customers. Identify and send case follow-up requests.
- Entry of safety data onto the safety databases and tracking systems. Maintain a strong understanding of the Quanticate safety database conventions or client specific database conventions, as appropriate.
- Coding of adverse events, medical history and medications either manually or using the auto-encoder.
- SAE reconciliation between the clinical trial (Case Report Form) and safety databases.
- Being aware of and working to the standards appropriate to the project (CRO or customer).
- Assist with weekly and ad-hoc global literature searches as required and as requested by the PV Scientist or above, ensuring adherence to timelines and processes specified in SOPs and project-specific Safety Plans.
- Assist with review and classification of literature abstracts and articles under the supervision of the PV Scientist or above.
- Ensure any ICSRs or safety concerns identified in the literature are logged and processed.
- Assist in the validation of the Safety Database by performing and documenting User Acceptance Testing.
- Assist in the testing of client Safety Databases prior to activation.
- Plan, organise and prioritise workload to deliver assigned projects and tasks in a timely manner and/or within agreed timelines if applicable.
- Collaborate effectively with colleagues to ensure timely and efficient completion of projects and tasks.
- Complete daily timesheets, providing an accurate record of time spent on activities.
- Support the Pharmacovigilance Lead on assigned projects as appropriate, generating first drafts of project documentation including Meeting Minutes and Serious Adverse Event report forms.
- Conduct ongoing document filing as appropriate and according to Standard Operating Procedures and project guidelines.
- Prepare any documentation for return to client/internal archiving at study completion as requested.
Other activities for the department
- Regulatory intelligence screening and analysis.
Audits and Inspections
- Prepare for and support back room activities during internal and client audits and inspections, and follow-up on findings as appropriate.
- Maintain 100% compliance with training curriculum (and any applicable client‑specific training).
- Perform other reasonable tasks as requested by management.
To fulfil job responsibilities in accordance with Good Clinical Practices (GCPs), Good Pharmacovigilance Practices (GVP), Company Standard Operating Procedures (SOPs), International Committee on Harmonization (ICH) Guidelines, and all applicable laws and regulations.