Sr. Manager, PV DM & Processing at Taiho Oncology in Princeton, New Jersey

Job Description:

Looking for a chance to make a real difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of cancer patients, their families, and caregivers. Our “People first” approach means we also value our employees, who work relentlessly to help us execute our mission. Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of our patients, our partners, and each other. Together, we’re working to discover and develop innovative cancer treatments that address unmet patient needs and apply the science behind them in novel ways. As the field of cancer treatment evolves, we evolve with it. Advanced technology, dedicated investigators, and incomparable facilities: these vast resources empower us to redefine the way the world treats cancer. It’s our work, our passion, and our legacy. If the prospect of being part of this sounds exciting, we invite you to join us.  

The incumbent is responsible for the safety database and its functionality within the Pharmacovigilance department. This includes all aspects of safety database management, including but not limited, to case processing or oversight, electronic submissions, database configuration including Health Authority reporting matrix, and safety database version upgrades. Work on projects of greater complexity and scope as it relates to the safety database.
 
 
Responsibilities:

• Oversees quality control management of work performed within the safety database internally or by PV vendor.


• Supports in the safety database administration for the Pharmacovigilance department.


• Supports system administrative task as needed under supervision.


• Supports registration and configuration of safety system including but not limited to Products, Licenses, Studies, Auto labeling, etc.    


• Supports E2B testing with required Health Authorities to obtain certification.
  


• Supports testing and validation of safety database/system updates and upgrades.


• Oversees and Develops safety system training materials and delivers training to both employees and PV vendor.
  


• Generates and/or Provides oversight of all necessary listings for aggregate reports, signal detection, monthly safety data review, GSPC, etc.


• Responsible for development and testing of automatic scheduling of regulatory reporting rules
  


• Supports and mentors’ team in relation to the safety data management activities and all information systems owned by TOI pharmacovigilance.


• Oversees improvements to safety systems to effectively use technology-enabled process solutions.
  


• Oversees business integration including safety data migration and integrating new assets or companies into Taiho PV system.


• Provides oversight and troubleshooting of all safety data submissions and exchanges with Health Authority and TOI business partners.
  


• Contributes to and develops new or revision of SOPs, work instructions, guidance in regards pharmacovigilance technological systems.


• Ensures inspection readiness of pharmacovigilance safety database.
  


• Establishes good communication and fosters relationships with all stakeholders including TPC, PV Vendors, and TOI business partners on all pharmacovigilance related issues.


• Supports internal PV meetings (Process improvement meeting, safety database team meetings, etc.) based on specific topics.

• Bachelor’s degree or equivalent in healthcare or technology discipline.   


• 7-10 years of progressive experience working with safety databases and electronic solutions in a pharmacovigilance department, as well as experience in managing adverse events processing on a global basis.


• Minimum 2-3 years of people management preferred


• Working knowledge of clinical trial setting.


• Knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonization (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.


• Working knowledge of ARISg safety databases, Aris Global LitPro, Aris Global Reporting and Analytics, and other electronic tools used in pharmacovigilance arena.


• Attention to detail with a highly consistent focus on quality.


• Working knowledge of drug development process.


• Ability to multi-task in a fast-paced environment.


• Demonstrated skills in verbal and written communication, planning, and organization.


• Ability to define problems, collect data, establish facts, and draw valid conclusions.


• Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables.


• Experience with the use of global safety databases is a plus. 


• Experience with Pharmacovigilance management tracking tools.


• Excellent PC skills including MS Office products (Word, Excel, and PowerPoint).