Pharmacovigilance Analytics Specialist

4 weeks ago

Trenton, New Jersey, United States TSR Consulting Full time
Job Title: Pharmacovigilance Specialist

The Pharmacovigilance (PV) Analytics and Reporting Specialist plays a pivotal role in driving 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.

Key Responsibilities:
  • 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.
  • 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.
  • 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.
  • Commitment to confidentiality and integrity.

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