- Strong experience and background with SAP Business Objects and IBM Cognos, as well as both Argus and
- ArisG drug safety databases, for the generation of queries in order to create and validate outputs for pharmacovigilance and inspection readiness.
- Skilled in generation of safety reports to define safety profile of products, both via aggregate reporting for PSURs and PBRERs as well as individual case reports (ICSRs).
- Worked with data modelling, interface between pharmacovigilance data - mining, Business Analysis, and application development.
- Provided quality control for drug safety-related data-mining and analysis.
- Has obtained a comprehensive knowledge and understanding regarding clinical trial and safety data both in terms of documents and data, regulations and requirements of health authorities, and how to implement this for pharmacovigilance reporting activities.
- Skilled at retaining a global business perspective in order to understand requirements and allocation of corresponding system resources.
Software: Microsoft Office (Word, Excel, Powerpoint), web-designer, Maple, SPSS, Spotfire
Languages: Java, C, C++, HTML, SAS, Oracle Clinical, Structured Query Language
Project Manager and Pharmacovigilance Software Support
- Involved in development and implementation of hosted pharmacovigilance software solutions for Vet and Human clients, such as PV-Works, a tool for case processing, reporting, and workflow
- Business Project Manager for PV-analyser, a pharmacovigilance signal detection, analysis, and reporting tool
- Bringing forward solutions to clients and customers in terms of development and enhancement of existing pharmacovigilance software tools, including Crystal Reports
- Leading projects in drug safety database scripting (SQL/Oracle), pharmacovigilance data analysis, licensing for vendor-related services (e.g. WHO-Drug dictionary)
Drug Safety Senior Systems Specialist
- Overall responsibility: Cognos Data Retrieval from Global Drug Safety Database and Support of Drug Safety Systems (Argus)
- Analysing and implementing functionality and operations of the Cognos reporting system to fulfil the reporting requirements of the Drug Safety and Pharmacovigilance Department (MDSP).
- Liaising directly with the business customers with regards to reporting requirements.
- Formulating and defining report scope and objectives based on both internal and external customer requirements and a thorough understanding of the business needs and the International Drug Safety Database (Argus) structure.
- Proactively identifying reporting solutions to MDSP to support / improve / streamline all aspects of the department function.
- Responsible for providing design, development, testing, validation, programming, delivery, modification, support and maintenance of regular and ad hoc reports.
- Responsible for creation and maintenance of documentation relating to Cognos Reporting System.
- Representing MDSP internationally with regards to Cognos Reporting System upgrades and validation, working within the Drug Safety Systems Team and alongside the US Drug Safety Systems (US DSS) team.
- Actively participating in the development, configuration and maintenance of the Drug Safety Systems, such as the International Drug Safety Database, SharePoint, email Inboxes, distribution lists and electronic document archive.
- Carrying out user maintenance for MDSP and external users (e.g. CROs) including creating new accounts and amending existing as required.
- Assisting in investigating and resolving issues relating to Drug Safety Systems, escalating to UK Service Desk, Purdue Pharma or the database vendor as required.
- Creating, reviewing and update department SOPs and Supporting Information Documents (SIDs) as required.
- Have obtained knowledge of Pharmacovigilance Regulatory Requirements so as to advise and provide for with regards to technical needs.
Patient Safety Systems Senior Scientist
- Involved in development, maintenance of BOBj universe for extracting / querying drug safety related data
- Leading optimization tasks (change requests) for the BOBj universe and reporting solutions that enable the optimal use of safety-related information and systems
- Fully responsible and accountable for creation of BOBj systems-related training materials, in terms of both content and delivery
- Managing “Superusers” group to ensure effective collaboration with entire AZ PV BOBj end-user community
- Actively interacting with lead for PV systems to provide technical input across a defined area of Patient Safety information and systems assets with regards to BOBj
- Direct deployed relationship with the PV Systems Lead to provide technical input on safety database and reporting projects, utilizing tools such as Business Objects, in-house drug safety database (SAPPHIRE), JASPER, and Empirica Signal, to meet business, partner, and customer needs.
- Accountable for ensuring effective collaboration with all Marketing Companies (MCs) to provide adequate BOBj reporting portfolio
- Enabling effective information management and information sharing activities within Patient Safety, in line with business priorities.
- Managing the delivery of enabling information solutions, applications and systems support to Patient Risk Management Planning activities, via the provision of scientific and technical expertise.
Strategic Data Analyst
- Taking ownership for internal and external medical requests that involve non-standard queries of the BI Global Drug Safety System (GDSS) databases, using IBM Cognos and ArisG database
- Collating results into descriptive analyses and presentations, check for consistency and overall plausibility
- Finding appropriate analytical schemes to explore and summarize the patient-, reaction-, treatment- and disease profile in adverse event reports, incl. temporal trending of case counts and adverse event reporting rates
- Identifying search strategies and prototype database queries applied on the GDSS using Cognos as a reporting tool
- Developing analytical schemes to transform database output into tabular/graphical results to address business requirements
- Working with other internal systems and business functions ( Corporate Finance, Corporate Business Analysis) to identify and explore supplementary datasets, including estimates of patient exposure based on product bulk units and prescription data. Extensive work with Qlikview, analysis of IMS data
- Working with Global Safety Evaluation to apply these models on post-marketing safety data in various indications, and discuss their strengths and limitations
- Acting as primary point of contact for Oncology Risk Management Therapeutic Area, for post-marketing safety surveillance
- Supporting validation of applications for data visualization and innovative schemes to explore patient safety profiles, by authoring system specifications and other documents relevant for validation
- Planning, execute, document, and review test cases
Clinical Trial Information Disclosure Specialist
- Cross-functional role to upload and submit registry for post-marketing studies and results data for all BI trials as required by internal and external legal requirements
- Data export and validation of Clinical Trial Management System protocol data for external platforms
- Uploading, Submission, and QA review of basic Trial Results data to NIH (clinicaltrials.gov) for established products (e.g. Spiriva, Telmisartan) as well as products recently receiving marketing approval (e.g. Linagliptin)
- Extensive work with document lifecycle management / tracking strategies (protocol, report review, analysis), Project management
- Quality management and review processes to ensure prompt publication of Trials on NIH Database
- Intensive cross-collaboration with wide-ranging interdisciplinary departments at BI, such as legal department (Patents), Therapeutic Area Heads (TAH), Trial Clinical Monitors (TCM), Trial Statisticians (TSTAT) to ensure accurate and acceptable data is submitted and published to NIH (ClinicalTrials.gov), in compliance with SOPs and internal guidelines
- Organized and provided 3-day training seminar to trial statisticians regarding compliance to SOPs and use of database system
- Provided feedback regarding writing of SOPs to reflect Boehringer interpretation of legal requirements
- Finding and implementing technical solutions for disclosure-related issues, including XML conversion tool. Troubleshooting of XML conversion strategies.
- Involved in planning and roll-out plan / pilot preparation for EudraCT (EMA) disclosure
- Extensive team work interaction, developed diligence and perseverance
- Disclosure efficiency ~ 97% performance level
Data Manager in Clinical Operations
- Managed projects which required validation of data transfer files, quality control checks for ECG overread, Holter, and Pulmonary function testing results, for clinical trials performed by large pharma company, from UAT to Live validation lifecycle processes.
- Created and established data management plan and data transfer specifications between sponsor; establishing document milestones (Draft vs. Final versions)
- Performed quality checks on database, validation / documentation of test and export scripts
- Contact with Data Quality Leads in order to ensure optimal quality data transfer. Skilled at organising TCs/presentations and communicating with sponsor via e-mail, telephone, etc. to ensure highest quality work.
- Involved in preparation of data format and mapping for statistical pre-analysis and analysis. Reviewed data structure and format created by programmers, in order to deploy to validation / live
- Performed SAS programming for exports. Developing and testing SAS programs for creation of export data transfer files.
- Performed query management and checking adherence to clinical trial workflows and User Requirement Specifications, via Data Correction Requests and changes to database
- Ran reconciliation processes between client's database and own database (InForm vs. own), tracking with eCRFs from sponsor
- Served as Head of sponsor-specific workstream data management standardisation team.
- Reviewed Vendor Specification / Data Transfer Agreements and providing optimal input for sponsor
- Managed Clinical Trial Data from study conception to study end (database lock/freeze) for 14 studies simultaneously
- Trained and supervised 3-4 internal assistants in data entry / data correction processing / query writing.
- Designed DCRFs (Data Correction Request Forms) for sites as paper-based method for Data Correction Requests
- Prepared graphs, reports, and charts for lead product development and optimisation. Wrote technical reports, documented protocols, and developed "Instructions for Use" on new product in pre-release stage.
- Involved optimising, testing, and validating results for a genome biomarker-based in-vitro diagnositc tool for sepsis detection (performed validation between clinical diganosis and "SIQ-score" results).