Senior Pharmacovigilance Associate
An exciting opportunity has arisen for a Senior Pharmacovigilance Associate to conduct and assist with ongoing pharmacovigilance operational activities in relation to data entry and processing of Individual Case Safety Reports (ICSRs), according to required SOPs, regulations, contracts and quality standards, under the direction of the Quanticate Team.
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 clientspecific training).
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.
Pharmacy, life science or healthcare degree. Higher degree or medical qualification desirable
Significant experience in ICSR processing, safety data management and safety data entry, gained within the pharmaceutical industry or with a CRO.
Knowledge of ICH GCP and other relevant regulations and guidelines.
Knowledge of industry-standard safety databases, such as Oracle Argus, ARISg or AB Cube SafetyEasy.
Good organisational and interpersonal skills, attention to detail.
Ability to work to tight timelines and feedback any issues quickly and effectively.
Good communication (oral and written) and analytical skills.
Efficient Team Player.
Good PC skills, including knowledge of Excel and Word.