Sr. Director, PV Medical Surveillance

Sr. Director, PV Medical Surveillance

Princeton, NJ, USA

Req #378

Monday, July 15, 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.

Hybrid

Employee Value Proposition:

Embark on a transformative journey with Taiho Oncology as a Sr. Director, PV Medical Surveillance . At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment where your expertise and leadership will drive meaningful impact. As an integral part of our team, you'll have the opportunity to shape the future of drug safety, contribute to groundbreaking research, and advance patient care worldwide. 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 the Taiho, marketed and/or investigational products assigned to him/her, 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. Typically assigned work of a more complex nature and/or global products that are marketed with risk management programs.

Performance Objectives:

Maintains expert 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

Attends cross functional and project specific team meetings to provide medical expertise.

Responsible for safety signal detection activities for assigned products and discusses safety signals as needed at Global Safety Monitoring Team (GSMT).

Responsible for contributing and review of aggregate reports (DSUR, PSUR/PBRER, RMP, ad-hoc safety reports) including but not limited to providing expert medical opinion. Drafts 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.

Chairs 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.

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

Responsible for 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 Data Sheets, Investigator Brochures, clinical summary of the NDA/MAA and product labeling.

Leads internal PV meetings (Process improvement meeting, etc. ) based on specific topics.

Education/Certification Requirements:

Medical degree (MD) or DO.

An oncology board certification is a plus, but not required.

At least 24 months direct patient clinical practice experience after received license or after earn the degree.

Knowledge, Skills, and Abilities:

Minimum of 5 years of experience in a Pharmacovigilance/Drug Safety environment with substantial experience in managing adverse event and SAE processing, medical surveillance and risk management, signal detection, on a global basis within the pharmaceutical industry.

Demonstrated leadership in medical surveillance issues and regulatory environment.

Knowledge of principles of epidemiology and statistics would be a plus.

Experience with the use of global safety databases, e. g. ARISg is a plus.

Experience with signal detection tool is a plus.

The candidate should have extensive knowledge of ICH/FDA/EMA guidelines for GCP and Clinical and post-marketing Safety Reporting.

Highly developed skills in verbal and written communication, planning, organization, with extensive knowledge of the investigational clinical study and post-marketing setting.

Expert understanding of the drug development process.

Ability to work in a highly organized team environment and project team environment.

Demonstrated decision-making and problem-solving skills coupled with a can-do attitude.

Ability to successfully lead and/or to manage and prioritize multiple critical issues simultaneously.

Attention to detail with a highly consistent focus on quality.

Ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents.

Ability to respond to inquiries or complaints.

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

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

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).

The pay range for this position at commencement of employment is expected to be between $287,300 - $338,000 annually; however, base pay offered may vary depending on multiple individualized factors, including m.