Associate Director, PV Medical Surveillance

Taiho Oncology, Inc.•Princeton, NJ

1d•Hybrid

About The Position

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. Hybrid Employee Value Proposition: 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. This is an exciting opportunity to work for early to late-stage global clinical trials and post-marketing products. You will contribute to the growth and exciting change happening at Taiho Pharmacovigilance and have greater opportunity to expose/contribute to the company’s portfolio. With competitive compensation, comprehensive benefits, and a commitment to professional development, Taiho empowers you to thrive personally and professionally. Join us in our mission to and be a part of the Taiho evolution to have your imprint based on your experience in our rapidly evolving organization. Position Summary: The incumbent will be responsible for global medical surveillance for Taiho, marketed and/or investigational products assigned, including review and analysis of safety data from clinical trials and from post-marketing sources, providing medical expertise to assigned project teams, the identification and investigation of safety signals, management of benefit-risk profile for assigned products and review of aggregate reports. Responsible for keeping upper management informed of safety issues. This is a critical role to ensure safety of patients taking Taiho investigational and marketed products.

Requirements

Medical degree (MD), DO or DMD/DDS.
At least 18 months direct patient clinical practice experience after received license or after earning the degree.
Minimum of 2 years of experience in a Pharmacovigilance/Drug Safety environment with experiences in managing adverse event and SAE processing, medical surveillance and risk management, signal detection, on a global basis within the pharmaceutical industry.
Experience with the use of global safety databases, e.g., ARISg/LSMV is a plus.
Experiences with the use of signal detection tools, is a plus.
Knowledge of principles of epidemiology and statistics would be a plus.
The candidate should have knowledge of ICH/FDA/EU/MHRA guidelines for GCP, GVP, and Clinical and post-marketing Safety Reporting.
Highly developed skills in verbal and written communication, planning, organization, with knowledge of the investigational clinical study and post-marketing settings.
Working knowledge of drug development process.
Ability to work in a highly organized team environment and project team environment.
Good decision-making and problem-solving skills coupled with a can-do attitude.
Ability successfully to manage and prioritize multiple critical issues simultaneously.
Attention to detail with a highly consistent focus on quality.
Ability to analyze, and interpret scientific and technical journals, financial reports, and legal documents.
Ability to respond to inquiries or complaints.
Ability to effectively present information to top management and boards of directors.
Ability to work with mathematical concepts such as probability and statistical measures.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical information and deal with several abstract and concrete variables.
Experience with drug safety management tracking tools and electronic databases.
Excellent PC skills including MS Office products (Word, Excel, and PowerPoint).
This position may require some travel.

Nice To Haves

An oncology board certification is a plus, but not required.
Experience with the use of global safety databases, e.g., ARISg/LSMV is a plus.
Experiences with the use of signal detection tools, is a plus.
Knowledge of principles of epidemiology and statistics would be a plus.

Responsibilities

Demonstrates knowledge of safety, including any emerging safety concerns and risk/benefit profile for responsible compounds, as well as regulatory guidelines as they pertain to drug safety/pharmacovigilance.
Responsible for Individual Case Safety Report (ICSR) review. Ensures completeness and accuracy of safety information in individual case reports through assessment of seriousness, expectedness, and causality, coding, review of narrative summary and providing case comments; provide medical inquiries for follow-up.
Advanced knowledge and understanding of regulatory requirements for ICSR submissions.
Responsible for AOSE comments for SUSAR cases for FDA/Health Canada submission.
Attends cross functional and project specific team meetings to provide medical input.
Responsible for participating in safety signal detection activities for assigned products and discuss safety signals as needed at Global Safety Management Team (GSMT) Meeting.
Responsible for contributing to, and review of aggregate reports (e.g., DSUR, PSUR/PBRER, RMP, ACO, ad-hoc safety reports) including, but not limited to, providing expert medical opinion.
Contributes to drafts of the appropriate safety sections as well as Risk/benefit sections for aggregate safety reports.
Provides medical opinion and safety input to inquiries from regulatory authorities, IRBs, ethics committees, etc
Participates in the GSMT for responsible products and works effectively with all cross functional stakeholders (internal and external) to discuss and manages all new emerging safety signals from post-marketing and clinical trials environment.
Establishes good communication and fosters relationships with cross boundary stakeholders including Taiho Pharmaceutical Co., Taiho World Wide, PV Vendors, and Taiho Partners on all pharmacovigilance related issues.
Responsible for participating in the maintenance and updating of benefit-risk profile for assigned products through product lifecycle.
Contributes and reviews safety sections of study reports, protocols, informed consents, Company Core Safety Information, Company Core Data Sheets, Investigator Brochures, clinical summary of the NDA/MAA and product labeling.
Attends internal PV meetings (process improvement meeting, etc.) based on specific topics.