The Pharmacovigilance (PV) Analytics and Reporting Specialist is responsible for executing and concluding activities that align with the vision and objectives of the Global Biostatistics & Data Sciences Function. This role contributes to the development, implementation, and execution of scientific, operational, and regulatory reporting efforts tailored to the needs of Worldwide Patient Safety. Reporting to the Senior Manager, the Specialist utilizes expertise in life sciences strategy, leadership, and reporting to effectively address information requirements across the organization.
Responsibilities include:
Data Analytics and Reporting
Enhance data analytics by supporting models that provide insights into efficiency, quality, stakeholder feedback, and key performance indicators, facilitating informed decision-making.
Maintain and develop reporting databases and analytics applications using tools such as Excel, Tableau, Spotfire, Power BI, and SAP Business Objects.
Optimize data and reporting processes by leveraging internal systems and tools to reduce manual data retrieval.
Collaborate with the validation team to create validation scripts, plans, and reports.
Participate in qualitative and quantitative research projects by analyzing data trends in partnership with cross-functional teams (e.g., Pharmacovigilance, Epidemiology).
Use data analysis tools to aggregate and analyze information, providing actionable recommendations and addressing key business inquiries.
Prepare and maintain reports on activities and outcomes, delivering presentations to management regularly and as needed.
Gather data for monthly reports and quarterly reviews regarding team activities, outcomes, and trends.
Stay informed about changes in the healthcare industry and their potential impacts on analytical programs and reporting mechanisms.
Analyze stakeholder complaints, address issues swiftly, and collaborate with functional leads to propose effective solutions.
Ensure data integrity and traceability throughout the transformation lifecycle.
Support program and project teams in implementing innovative initiatives.
Assist in managing and prioritizing process improvement and innovation efforts.
Define and provide metrics and analysis for GBDS/WWPS initiatives, offering insights for decision-making.
Evaluate the process impacts of new PV tools and methodologies.
Required Skills/Knowledge:
Background in Life Sciences, Information, or a related field (Bachelor's or Master's degree).
Over 5 years of experience in Drug Safety/Pharmacovigilance.
Proficiency in Tableau, Spotfire, Power BI, and SAP Business Objects with at least 5 years of development experience.
Familiarity with databases (e.g., Postgres, Oracle, MS Access).
Experience with programming languages (SQL, VBA, Python).
Knowledge of reporting platforms (Cognos, SAP-Business Objects).
Understanding of commercial coding dictionaries (MedDRA, WHO Drug).
Ability to synthesize scattered information into a coherent overview.
Knowledge of taxonomies, ontologies, and knowledge management constructs.
Strong analytical and strategic thinking skills.
Proficiency in PowerPoint, Word, and Excel.
Familiarity with validation processes and related documentation.
Excellent verbal and written communication skills, along with project management capabilities.
Strong strategic orientation, translating goals into actionable plans.
Ability to foster cooperation within teams to achieve objectives.
Experience resolving complex issues and managing stakeholder relationships.
Capacity to lead critical path analyses and support scenario planning.
Proactive decision-making skills, ensuring timely information coordination.
Proven ability to handle multiple projects simultaneously.
Collaborative approach with a willingness to work across functions.
Flexible team player with a positive attitude, adept at prioritizing and balancing competing tasks.