Overall Purpose of the Job
• Performs quality control of data processing in the safety database for received source documents of cases collected during safety monitoring of drugs and compounds, which includes triage, data entry, coding and narrative writing of individual case safety reports. Within agreed timeframes and to a high standard of accuracy, in compliance with Customer business rules, standard operating procedures and global regulatory requirements as documented in Customer’s SOPs
• Ensures integrity and consistency of data against source document by performing QC and appropriate correction of all processed cases in appropriate timelines as per standard operation procedures.
• Drives quality improvement by identifying individual quality defects, analysing trends and providing feedback to case processing associates.
• Quality Control Associate with a minimum of 1-2 years of PV ICSR case processing experience. Experience with peer QC of ICSR cases.
• Good understanding of drug safety, Individual Case Safety Reports and global regulatory requirements.
• Good knowledge of medical terminology including knowledge of applicable dictionaries like MedDRA and WHO-Drug Dictionary.
• Hands-on experience of working on a Safety database.
• A life science professional by qualification.
Key Expertise and Skills
• Strong Communication skills in English
• ICSR Case intake, processing and QC
• Attention to detail
• Analytical ability
• Ability to work independently under tight time constraints.
• Team worker
• Training and presentation skills
Selected Relevant Experience
• Pharmacovigilance experience with ICSR case processing experience of 1-2 years. Experience performing peer QC as per the defined Client SOPs, scorecard and requirements on ICSR data within the Client’s Safety database. Experienced in handling CAPA and deviation.
• Good understanding of the applicable PV regulations and guidelines specifically GVP Module VI and FDA 314.80 and 314.98
• Responsible for performing Quality Checks for cases entered in the Argus Safety database in ordinance with the applicable SOP.
• Responsible for performing Quality checks with reference to the agreed quality parameters and documenting the QC results in the checklist/scorecard.
• Performing the corrections in the case and communicating the findings to the case processor.
• Experience of collaborating with managers to implement process improvements and track and escalate issues or team’s training needs.
• Support the team during audits and inspections
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