Sr. Specialist, PV Vendor Mgmt. & Bus. Integration (Marketing)
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:
As the Sr. Specialist, you will support the Vendor Management & Business Integration activities within the Quality, Standards, and Training (QST) function. You will be responsible for supporting PV vendor oversight including tracking key performance indicators (KPIs) and ensuring quality of the work performed at a case level. Support workflow compliance, health authority submissions, corrective and preventive actions (CAPAs) and relationship between Taiho and PV vendors. Work cross-functionally with stakeholders and external resources on pharmacovigilance related matters for business integration activities.
Responsibilities and Duties:
- Support activities related to the governance structure between Taiho, and PV vendors.
- Support the oversight of PV Vendors; including and not limited to oversight of reconciliations, ICSR case quality metrics and outsourced case processing activities.
- Work with the Taiho QST team to ensure PV vendors have been trained, and are provided with all necessary materials.
- Support the consolidation of vendors performing PV activities.
- Participate in process improvement and vendor-client Safety Management Plans and timelines for processing and reporting safety data from clinical trials and post-marketing surveillance.
- Support activities related to business integration which includes safety data migration, and integrating new assets or companies into the Taiho PV system.
- Participate in the Quality Management System within PV including compliance, ensuring the use of best practices, and continuous process improvements.
- Support the development of SDEAs or pharmacovigilance agreements with Taiho partners and vendors for specific obligations for safety data exchange and reporting.
- Work with all departments at TOI to streamline processes related to safety reporting and best practices.
- Contribute to the inspection readiness and support Health Authority inspections of Taiho's pharmacovigilance function.
- Participate in internal PV meetings (Process improvement meeting, safety database team meetings, etc.) based on specific topics.
Experience:
- Bachelor's degree in healthcare related field required. RN, R.Ph., or Pharm D. preferred.
- Minimum of 5 years' progressive experience in pharmacovigilance in a pharmaceutical, biotech or related environment.
- Minimum of 3 years' experience with ICSR case processing.
- 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.
- Working knowledge of monitoring workflow compliance, health authority submissions, CAPAs and relationships between PV vendors.
- Working knowledge of safety databases and other electronic tools used in pharmacovigilance arena.
- Working knowledge of drug development process.
- Experience with the use of global safety databases is a plus.
- Experience with Pharmacovigilance management tracking tools.
