Sr. Specialist, Case Processing & QC 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 supports the Vendor Management & Business Integration activities
within the Quality, Standards, and Training (QST) function.   Responsible for supporting PV vendor
oversight and ensuring quality of the work performed at a case level is in
accordance with pharmacovigilance (PV) procedures and SOPs.  This position will oversee activities related
to the collection, processing, follow-up, analysis, and regulatory reporting of
adverse events (AEs) and serious AEs (SAEs) ICSR reports.
 

Responsibilities
and Duties: 

• Perform
  quality review of ICSRs which includes review of source documents and ensuring
  that the case is accurate and that corrections to the case, if applicable, are
  incorporated.


• Liaison with
  PV Medical Reviewers and team members as appropriate to clarify appropriate
  information required for case processing.


• Other
  activities relating to case processing as appropriate, including but not
  limited to:




• Serious
  Adverse Event (SAE) /Adverse Event (AE) reconciliation


• CAPA/Deviation
  memo preparation


• Input to
  company procedures and guidance


• Completion
  of all assigned training on company procedural documents relating to case
  processing


• Completion
  of training relating to relevant PV Agreements for assigned products




• Participate
  in designated activities to support revision/creation of case processing
  procedural documents


• Supports
  activities related to the governance structure between TOI and PV vendors.


• Supports
  monitoring of PV vendors for all work performed.


• Supports to
  ensure PV vendors have been trained and are provided with all necessary
  materials in collaboration with QST Training function.


• Participates
  in the Quality Management System within PV including compliance, best
  practices, and continuous process improvements.


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


• Contributes
  to inspection readiness and supports Health Authority inspections of Taiho’s
  pharmacovigilance function.


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

Educational
Requirements:  

• Bachelor’s
  degree or higher in pharmacy, nursing, healthcare or life-sciences related
  field.   RN, RPh., or Pharm D. degree is
  highly preferred.

Experience: 

• Minimum of 3
  years’ experience in pharmacovigilance in the pharmaceutical/biotech industry.


• Minimum of 2
  years’ experience with ICSR case processing is required.


• Oncology
  experience is highly preferred.

Other Skills
and Abilities:

• Working
  knowledge of clinical trial and post marketing settings.


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


• Experience
  working with a drug safety database, with working knowledge of MedDRA and
  familiarity with common safety databases (e.g. ARISg, Argus, AERS)


• Proficiency
  in writing narratives and performing critical quality review of AEs/SAEs


• Excellent
  attention to detail, initiative, resourcefulness, accountability, and teamwork


• Ability to
  prioritize and work independently with minimal supervision and guidance


• Excellent
  verbal and written communication skills


• Ability to
  work with mathematical concepts such as probability and statistical inference.


• Ability to
  apply concepts such as fractions, percentages, ratios, and proportions to
  practical situations.

Reasoning
Ability:

• Analytical
  thinker with excellent problem-solving skills and the ability to adapt to
  changing priorities and deadlines.

Computer
Skills:

• 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).