88-50101435 Senior Pharmacovigilance Analyst

Roche•South San Francisco, CA

1d•Hybrid

About The Position

The Position Genentech, Inc. seeks a Senior Pharmacovigilance Analyst at its South San Francisco, CA location. Duties: Responsible for the analysis and trending of a variety of complex datasets within safety reporting and forecasting across US Patient Safety (US PS) for enhanced efficiency and improvement of pharmacovigilance (PV) processes. Collaborate within cross-functional teams of both local and global stakeholders to develop data solutions, gain alignment and deliver impactful business insights, acting as a thought partner to enable better data driven decision-making. Manage and participate at an advanced level in the development of programs (Python, SAS, Tableau, Excel, etc.) and related automated dashboards that perform complex data analyses that answer a wide array of business questions across multiple domains - including Adverse Events, Product Complaints, Market Research and Patient Support Programs (MAPs), and PV systems - using multiple complex data sources and technical tools/languages. Responsible for the management of data, programming of data edit checks for data cleansing, and sophisticated data visualizations. At a senior level, develop optimized programs to provide ad-hoc reports for data review to support US Patient Safety across the department. Responsible for the testing and organization of data transfers, datasets, programs, and related documentation. Ensure all data programming activities and processes are conducted according to standard operating procedures and good programming practice. Manage data projects using established project management methodologies, ensuring timely execution, cross-functional alignment, and successful launch. Collaborate with leadership to address internal and external data needs/gaps at a senior level. Recommend and implement sampling strategy. Develop, expand, and manage U.S. forecasting strategy across various lines (adverse events, product complaints, follow-ups, therapeutic areas and sender units) in collaboration with global partners, contributing insights to forums that guide forecast alignment across global affiliates and ensuring collection of stakeholder data both internally and externally. Develop and execute resource models to estimate staffing needs for both U.S. and global patient safety teams. Act as subject matter expert for data analytics, including advanced analytical methodologies, programs/projects, and health authority audits and inspections. Actively participate in cross functional communities, networks and/or knowledge-sharing bodies that enable broader and more effective use of insights and/or analytics that drive and support decisions. Develop and model data analytics best practices. Represent US affiliate on global work streams or committees. Stay current with and adopt emergent relevant methodologies, tools and applications to ensure fit-for-purpose and impactful approaches. Telecommuting permitted up to 3 days per week.

Requirements

Master’s degree in Business Analytics, Mathematics, Statistics or related quantitative field, and 5 years of experience in data science, business analytics or closely related role
Must have 5 years of work experience with each of the following, including 3 years in the pharmaceutical or biotech industry: Design and implementation of statistical, machine learning and time-series forecasting models in Python and R including Clustering, Logistic Regression, ARIMA and SARIMA models.
Use of Tableau to develop interactive dashboards and reports to effectively communicate data findings and trends
Use of relational databases and programming languages including SQL, Python, R and SAS to reconcile, manipulate, and test accuracy of data, and to analyze and visualize complex datasets, create automated processes, and develop scalable workflows
Consultation with users on automated systems and leading cross-functional teams to address business or systems issues
Designing and implementing sampling strategies, including random and stratified, to ensure representative data collection and applying statistical inference techniques, including hypothesis testing, to draw meaningful conclusions.
Must have at least 1 year of experience with each of the following: Delivering data with strict adherence to data integrity standards to support regulatory audits and inspections by US and international health authorities
Pharmacovigilance data analytics and analysis of pharmaceutical product trends and patient safety datasets using pharmacovigilance systems to generate AE monitoring and mitigate regulatory compliance risks
Development of high-impact forecasting models for vendor resource planning and ensuring regulatory compliance.

Responsibilities

Responsible for the analysis and trending of a variety of complex datasets within safety reporting and forecasting across US Patient Safety (US PS) for enhanced efficiency and improvement of pharmacovigilance (PV) processes.
Collaborate within cross-functional teams of both local and global stakeholders to develop data solutions, gain alignment and deliver impactful business insights, acting as a thought partner to enable better data driven decision-making.
Manage and participate at an advanced level in the development of programs (Python, SAS, Tableau, Excel, etc.) and related automated dashboards that perform complex data analyses that answer a wide array of business questions across multiple domains - including Adverse Events, Product Complaints, Market Research and Patient Support Programs (MAPs), and PV systems - using multiple complex data sources and technical tools/languages.
Responsible for the management of data, programming of data edit checks for data cleansing, and sophisticated data visualizations.
At a senior level, develop optimized programs to provide ad-hoc reports for data review to support US Patient Safety across the department.
Responsible for the testing and organization of data transfers, datasets, programs, and related documentation.
Ensure all data programming activities and processes are conducted according to standard operating procedures and good programming practice.
Manage data projects using established project management methodologies, ensuring timely execution, cross-functional alignment, and successful launch.
Collaborate with leadership to address internal and external data needs/gaps at a senior level.
Recommend and implement sampling strategy.
Develop, expand, and manage U.S. forecasting strategy across various lines (adverse events, product complaints, follow-ups, therapeutic areas and sender units) in collaboration with global partners, contributing insights to forums that guide forecast alignment across global affiliates and ensuring collection of stakeholder data both internally and externally.
Develop and execute resource models to estimate staffing needs for both U.S. and global patient safety teams.
Act as subject matter expert for data analytics, including advanced analytical methodologies, programs/projects, and health authority audits and inspections.
Actively participate in cross functional communities, networks and/or knowledge-sharing bodies that enable broader and more effective use of insights and/or analytics that drive and support decisions.
Develop and model data analytics best practices.
Represent US affiliate on global work streams or committees.
Stay current with and adopt emergent relevant methodologies, tools and applications to ensure fit-for-purpose and impactful approaches.