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Sr. Specialist, Case Processing & QC job

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Taiho Oncology jobs
Job Code:  2806
Employer:  Taiho Oncology
Country:  United States
03/14/2024

Description
Sr. Specialist, Case Processing & QC

Virtual Req #348

Thursday, March 14, 2024

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our "People first" approach means we also highly value our employees, who work relentlessly to help 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 patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It's our work, our passion, and our legacy. We invite you to join us.

Remote

Employee Value Proposition:

Taiho Oncology is a Japanese company specializing in the development and commercialization of orally administered anti-cancer agents. Our mission is to improve the lives of patients with cancer, their families, and their caregivers. Whether it's our patients or employees, people come first at Taiho. The compassion we practice for our patients extends to our team, empowering and motivating them to do their best work for those who need it most. Our culture is inclusive and our leadership ensures an environment which encourages employees to be accountable for their own successes. We hold ourselves and each other to a high bar of executional excellence because patients are counting on us. Collaboration and trust are additional core principles operating at Taiho which sets us apart from other organizations. These principles foster open communication and fun atmosphere. Respect, dignity, compassion and kindness are required of each of employee. We believe that honesty and integrity are critical to our business and our actions earn each other's trust and the trust of the community we serve.

Position Summary:

The incumbent supports the Global PV Operations activities within the Quality, Standards, and Training (QST) function. Responsible for supporting global PV vendor oversight and ensuring quality of the work performed at a case level is in accordance with global 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.

Performance Objectives:
  • 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 Taiho and global PV vendors.
  • Supports monitoring of global PV vendors for all work performed.
  • Supports to ensure global 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 Taiho 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.

Education/Certification Requirements:
  • Bachelor's degree or higher in pharmacy, nursing, healthcare or life-sciences related field. RN, RPh., or Pharm D. degree is highly preferred.

Knowledge, Skills, and Abilities:
  • 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.
  • 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
  • Demonstrated skills in verbal and written communication, planning, and organization.
  • 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.

The pay range for this position at commencement of employment is expected to be between $113,900 - $134,000 annually; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as PTO, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

#LI-Remote

Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please email People@taihooncology.com . Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.

The incumbent in this position may be required to perform other duties, as assigned.
ref: (2806)
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