C08 - MEDICAL AND REGULATORY AFFAIRS / PHARMACOVIG - PHARMACOVIGILANCE SPECIALIST

TechDigital Group; Lawrenceville (NJ); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a skilled Pharmacovigilance Analytics and Reporting Specialist to join their dynamic team. This role involves leveraging advanced data analytics tools to drive insights into drug safety and regulatory reporting. You will collaborate across functions to enhance reporting processes and ensure data integrity. The ideal candidate will have a strong background in life sciences, with expertise in tools like Tableau and Power BI, and a passion for data-driven decision-making. Join this innovative firm and contribute to impactful projects that shape the future of healthcare analytics.

Qualifications

• 5+ years experience in Drug Safety/Pharmacovigilance with strong analytical skills.
• Proficient in advanced data analytics tools and reporting platforms.

Responsibilities

• Drive data analytics and reporting for informed decision-making.
• Collaborate with cross-functional teams to enhance reporting processes.

Skills

Drug Safety/Pharmacovigilance

Tableau

Spotfire

Power BI

SAP Business Objects

SQL

VBA

Python

Data Analysis

Analytical Thinking

Project Management

Communication Skills

Education

Bachelor's in Life Sciences or Information

Master's in Life Sciences or Information

Tools

Excel

Tableau

Spotfire

Power BI

SAP Business Objects

Postgres

Oracle

MS Access

Impala

SharePoint List

Job description

Position is Onsite (Lawrenceville/New Brunswick)

Pharmacovigilance (PV) Analytics and Reporting Specialist, PV Analytics Center of Excellence JD

The Pharmacovigilance (PV) Analytics and Reporting Specialist, PV Analytics Center of Excellence is responsible for successful execution and close-out of activities aligned with the overall vision, strategy, and objectives of the Global Biostatistics & Data Sciences Function. The PV Analytics and Reporting Specialist contributes to the ongoing development, implementation, and successful execution of the scientific, operational, and regulatory reporting efforts in line with the overall WWPS needs. The PV Analytics and Reporting Specialist reports to the Senior Manager, PV Analytics Center of Excellence, within Global Biostatistics & Data Sciences. The PV Analytics and Reporting Specialist applies a combination of life sciences strategy, leadership, and reporting/visualization experience to drive successful servicing of information needs across WWPS.

Responsibilities include, but are not limited to the following:

1. Data Analytics and Reporting
2. Build and continuously improve data analytics through supporting models that provide insights into efficiency, quality, stakeholder feedback, and key performance indicators to drive timely and informed decision making.
3. Maintain and develop reporting databases and analytics applications in environments such as Excel, Tableau, Spotfire, Power BI, SAP Business Objects and/or other Client environments.
4. Leverage internal data systems and tools to efficiently maintain data and reporting processes to minimize manual data retrieving.
5. Liaison with validation team to create validation test script, validation plan, validation summary report and test scripts.
6. Contribute to qualitative and quantitative research projects through collaboration with data trends from cross-functional teams (Pharmacovigilance, Epidemiology, etc.).
7. Utilize data analysis tools to aggregate and analyze data to make actionable recommendations and answer key business questions.
8. Run and maintain reports regarding activities, outcomes, and be prepared to deliver presentations to management team on a regular and ad-hoc basis.
9. Collect data for monthly reports and quarterly reviews regarding activities, outcomes, and trends of the Advisor team.
10. Continually remain apprised of the constantly changing landscape of the healthcare industry and any impacts it may have to our Analytical programs and reporting mechanisms.
11. Analyze key stakeholder complaints, address rapidly, and discuss with applicable functional leads to collaborate and propose impactful and realistic solutions.
12. Maintain data integrity and traceability across the transformation lifecycle from the Source to Target.
13. Support program and project team activities required to implement innovation initiatives.
14. Contribute to the management and prioritization of process improvement and innovation initiatives.
15. Define and provide metric reporting and data analysis for GBDS/WWPS initiatives including relevant insights to facilitate decision-making process.
16. Assess and interpret the process impact of new PV tools and processes.

Skills/Knowledge Required:

1. Life Sciences, Information, or similar background (Bachelors, Masters).
2. 5+ years Drug Safety/Pharmacovigilance experience.
3. Advanced Tableau, Spotfire, Power BI, SAP Business Objects (BO) skills with 5+ years of development experience.
4. Databases (Postgres, Oracle, MS Access, Impala, SharePoint List etc.).
5. Programming languages (SQL, VBA, Python etc.).
6. Reporting platforms and services (Cognos, SAP-Business Objects, Power BI etc.).
7. Knowledge and application of commercial coding dictionaries (MedDRA, WHO Drug).
8. Ability to organize/curate data and see big picture from scattered pieces of information.
9. Knowledge of taxonomies, ontologies, and other knowledge management constructs.
10. Analytical and strategic thinking skills required.
11. Strong PowerPoint, Word, and Excel Skills.
12. Knowledge of Validation processes and associated documentation.
13. Excellent verbal, writing, presentation, and project management skills.
14. Strong strategic orientation with ability to translate into operational priorities and plans.
15. Ability to promote cooperation and commitment within a team to achieve goals and deliverables.
16. Ability to resolve complex problems and manage difficult stakeholder situations.
17. Ability to lead the development of critical path analyses and support scenario planning.
18. Promotes and practices effective pro-active decision-making, ensuring timely coordination and dissemination of information.
19. Demonstrated ability to work on multiple projects.
20. Strong willingness to collaborate with cross-functional partners.
21. Flexible, team member with positive attitude, friendly demeanor, ability to prioritize projects and balance competing priorities.
22. Confidentiality and integrity are required.