Sr. Specialist, PV QMS & Training 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.
 

Position Summary:       

The incumbent will assist with the
oversight and/or support, of all listed activities related to the maintenance
of the Quality Management System and Trainings function within the PV
department.   Responsible for supporting inspection readiness
of the PV Department/designees for Taiho. 
Supports in the overall compliance with SDEAs and any PV contracts. Supports
activities to ensure CAPA plans are completed in timely manner. Supports
activities to ensure appropriate standard operating procedural (SOPs) documents
are in place based on business needs and global regulations. Also contributes
to, the development or revision of existing PV processes related the Quality, Standards,
and Training function.   The incumbent
works cross-functionally with stakeholders and external resources on
pharmacovigilance-related matters.

Responsibilities and Duties: 

• Supports the maintenance and development of
  the global PV quality management system.


• Assists with activities related to the overall
  PV Compliance with all health authority guidance and regulations.


• Coordinates
  all vendor training and tracks all PV related training to ensure it has been
  completed and documented appropriately


• Supports the corrective action and prevention
  activities (CAPAs) within PV and follows through on all commitments.


• Supports Process Improvements initiatives for
  the PV department.


• Supports inspection readiness of the PV
  department.


• Supports activities related to the consolidation
  of PV vendors providing services.


• Supports
  the development or revision of SOPs, work instructions, or guidance with regard
  to Vendor Oversight and QST activities.


• Supports
  the development of SDEAs or pharmacovigilance agreements with Taiho partners
  and vendors for specific obligations for safety data exchange and reporting as
  needed.


• Collaborates
  with all departments at TOI to streamline processes related to safety reporting
  and best practices.  


• Supports
  good communication and fosters relationships with all stakeholders including
  TPC, PV Vendors, and Taiho Partners on all pharmacovigilance related issues.


• Leads internal PV meetings related to QST (e.g. Process
  improvement meetings, Quality review etc.).

Educational Requirements:   

Bachelor’s degree or equivalent in healthcare.  RN, RPh, or Pharm D.
 

Experience: 

• Minimum of 5 years progressive experience in pharmacovigilance in
  a pharmaceutical, biotech or related environment.


• Minimum of 3
  years of experience with ICSR case processing.


• Working knowledge of clinical trial (CT) and
  post-marketing (PM) settings.


• Working knowledge of  CT and PM
  submissions to Health Authorities (FDA, HC, EU).


• Previous QMS experience preferred, including compliance tracking
  and preparing compliance metrics presentations.


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


• Working knowledge of safety databases, electronic learning management
  systems (eLMS), and compliance tracking tools.


• Experience with the development of training
  materials.


• Ability to effectively deliver training to internal groups or external
  stakeholders.


• Experience with creation and review of corrective and preventative
  action (CAPA) reports.