Director, PVER Analysis and Reporting Operations Head
Janssen Research & Development, LLC., a member of the J&J Family of Companies, is recruiting for aDirector, Pharmacovigilance Evaluation and Reporting (PVER) Analysis and Reporting Operations Head to be based in Horsham, PA, Raritan, NJ, or Titusville, NJ and will require up to 10% travel.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Director, Pharmacovigilance Evaluation and Reporting (PVER) Analysis and Reporting Operations Head will be responsible for the systems, tools, and processes that enable the scientific analysis and reporting responsibilities of the group in order to maintain regulatory compliance and produce high quality safety evaluations. The position will represent group requirements for systems and tools and will be accountable for efficient documentation and archival of Safety Management Team documents and aggregate safety reports that are submitted to Health Authorities. The systems and tools may include the global safety database repository, aggregate report calendar, and workflow management tool. The position will also be responsible for metrics, post-marketing exposure, process efficiency/improvement, and procedure management. The position will be a member of the PVER leadership team and will include direct reports.
- Develop strategy for PVER systems and tools and ensure implementation
- Manage the aggregate report calendar and negotiate with internal partners to align off-cycle reports and meet health authority requirements
- Implement workflow management tool
- Partner with internal and vendor team on global safety database repository
- Develop and maintain an efficient documentation and archival process for SMT documents and aggregate safety reports
- Strategize, develop opportunities for, and oversee processes and deliverables
- Procedural documents
- People Management
- Serves as front-line for PV audits and inspections
- Advanced degree preferred. Bachelor's degree required.
- At least 9 years of experience in Pharmacovigilance, Aggregate Reporting, or comparable regulated environment with operational leadership in a multi-function organization preferred
- At least 6 years of experience leading in a global organization preferred
- Experience in the areas of systems, workflow management, project management, quality, metrics, process excellence, and documentation/archival is preferred
- People management experience preferred
- Subject matter expertise helpful to succeed in this role:
- Knowledge of global regulatory framework for aggregate safety reports
- Experience in developing aggregate safety reports (e.g., PBRER)
- Attention to detail along with strong analytical and conceptual skills
- Understand aspects and methods for data analysis, interpretation and presentation
- Ability to effectively interact with external stakeholders, including business partners
- Ability to manage/lead in a matrix environment, proven leadership skills
- Excellent verbal and written communication skills
- Ability to plan work to meet deadlines and effectively handle multiple priorities
- Proficiency in Microsoft Word, Excel, and PowerPoint
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
North America-United States-Florida-Titusville, North America-United States-New Jersey-Raritan
Janssen Research & Development, LLC. (6084)
Drug & Product Safety Science
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