Taiho Oncology, Inc.
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Associate Director, PV Sciences
role at
Taiho Oncology, Inc.
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.
Hybrid Employee Value Proposition Embark on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment where your expertise and leadership will drive meaningful impact. With competitive compensation, comprehensive benefits, and a commitment to professional development, Taiho empowers you to thrive personally and professionally.
Position Summary The Associate Director, PV Sciences role will lead medical surveillance activities for assigned products in collaboration with the Medical Surveillance Physician. The incumbent is expected to work cross‑functionally with key internal and external stakeholders, as well as other pharmacovigilance resources.
Performance Objectives
Lead aggregate reports (e.g., DSUR, PBRER, topic reports) for assigned products.
Support Medical Surveillance Physicians toward product benefit‑risk assessment and related activities of assigned product(s).
Collaborate with Medical Surveillance Physicians for ad‑hoc and routine Global Safety Management Team (GSMT) meetings.
Lead signal‑management activities in collaboration with the Pharmacovigilance team.
Lead development/maintenance of Risk Management Plans (RMP) and associated pharmacovigilance and risk minimization activities.
Participate in new study initiation to ensure PV requirements are met, including safety reporting, query resolution, SAE reconciliation, un‑blinding process, and safety reporting training.
Review protocols, informed consents, Company Core Data Sheets, Investigator Brochures, clinical summaries of the NDA/MAA, product labeling, and other applicable documents for clinical trials.
Evaluate current processes and propose enhancements to improve medical surveillance and risk‑management processes.
Oversee approval of Safety Reporting Plans as applicable.
Develop or update SOPs, Working Instructions, and training materials for applicable tasks.
Collaborate with internal and external stakeholders outside Taiho (e.g., business partners).
Ensure compliance with regulatory submissions and internal timelines.
Serve as subject‑matter expert during audit preparedness activities and regulatory inspections.
Maintain training and oversight for clinical operations/pharmacovigilance vendors.
Perform other supporting activities as requested by supervisor.
May have direct reports (other PV Scientists or consultants).
Education/Certification Requirements
Bachelor’s degree in a health‑care related discipline or equivalent. RN, R.Ph., or Pharm.D. preferred.
Knowledge, Skills, And Abilities
Minimum of 8–10 years of progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology, or related environment.
Proficiency in signal detection, safety surveillance, risk mitigation, and risk‑management.
Experience directly managing people and/or leading a cross‑functional team is a plus.
Expertise in FDA, EU, and ICH guidelines and regulations governing pharmacovigilance.
Extensive knowledge of MedDRA.
Hands‑on experience improving departmental processes for efficiency and quality.
Excellent verbal, written, and interpersonal communication skills.
Ability to work independently and collaboratively in a fast‑paced, matrixed environment.
Excellent planning, organization, and time‑management skills.
Ability to influence without direct authority.
Analytical thinking and problem‑solving skills.
Proficiency with mathematical concepts (probability, statistical inference, fractions, percentages, ratios).
The incumbent may be required to perform other duties as assigned.
Compensation The pay range for this position at commencement of employment is expected to be between $192,950 and $227,000 annually. Base pay offered may vary based on location, experience, and other factors. Total compensation may include bonus/incentive plans, long‑term incentive plans, and discretionary awards, along with full medical, financial, and other benefits (401(k), paid time off, parental leave).
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, age, religion, creed, national origin, or any other protected characteristic. For applicants who require accommodation due to a disability, please contact People@taihooncology.com.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Research, Analyst, and Information Technology
Pharmaceutical Manufacturing
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Associate Director, PV Sciences
role at
Taiho Oncology, Inc.
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.
Hybrid Employee Value Proposition Embark on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the forefront of pharmacovigilance innovation, we offer a dynamic and collaborative environment where your expertise and leadership will drive meaningful impact. With competitive compensation, comprehensive benefits, and a commitment to professional development, Taiho empowers you to thrive personally and professionally.
Position Summary The Associate Director, PV Sciences role will lead medical surveillance activities for assigned products in collaboration with the Medical Surveillance Physician. The incumbent is expected to work cross‑functionally with key internal and external stakeholders, as well as other pharmacovigilance resources.
Performance Objectives
Lead aggregate reports (e.g., DSUR, PBRER, topic reports) for assigned products.
Support Medical Surveillance Physicians toward product benefit‑risk assessment and related activities of assigned product(s).
Collaborate with Medical Surveillance Physicians for ad‑hoc and routine Global Safety Management Team (GSMT) meetings.
Lead signal‑management activities in collaboration with the Pharmacovigilance team.
Lead development/maintenance of Risk Management Plans (RMP) and associated pharmacovigilance and risk minimization activities.
Participate in new study initiation to ensure PV requirements are met, including safety reporting, query resolution, SAE reconciliation, un‑blinding process, and safety reporting training.
Review protocols, informed consents, Company Core Data Sheets, Investigator Brochures, clinical summaries of the NDA/MAA, product labeling, and other applicable documents for clinical trials.
Evaluate current processes and propose enhancements to improve medical surveillance and risk‑management processes.
Oversee approval of Safety Reporting Plans as applicable.
Develop or update SOPs, Working Instructions, and training materials for applicable tasks.
Collaborate with internal and external stakeholders outside Taiho (e.g., business partners).
Ensure compliance with regulatory submissions and internal timelines.
Serve as subject‑matter expert during audit preparedness activities and regulatory inspections.
Maintain training and oversight for clinical operations/pharmacovigilance vendors.
Perform other supporting activities as requested by supervisor.
May have direct reports (other PV Scientists or consultants).
Education/Certification Requirements
Bachelor’s degree in a health‑care related discipline or equivalent. RN, R.Ph., or Pharm.D. preferred.
Knowledge, Skills, And Abilities
Minimum of 8–10 years of progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology, or related environment.
Proficiency in signal detection, safety surveillance, risk mitigation, and risk‑management.
Experience directly managing people and/or leading a cross‑functional team is a plus.
Expertise in FDA, EU, and ICH guidelines and regulations governing pharmacovigilance.
Extensive knowledge of MedDRA.
Hands‑on experience improving departmental processes for efficiency and quality.
Excellent verbal, written, and interpersonal communication skills.
Ability to work independently and collaboratively in a fast‑paced, matrixed environment.
Excellent planning, organization, and time‑management skills.
Ability to influence without direct authority.
Analytical thinking and problem‑solving skills.
Proficiency with mathematical concepts (probability, statistical inference, fractions, percentages, ratios).
The incumbent may be required to perform other duties as assigned.
Compensation The pay range for this position at commencement of employment is expected to be between $192,950 and $227,000 annually. Base pay offered may vary based on location, experience, and other factors. Total compensation may include bonus/incentive plans, long‑term incentive plans, and discretionary awards, along with full medical, financial, and other benefits (401(k), paid time off, parental leave).
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, age, religion, creed, national origin, or any other protected characteristic. For applicants who require accommodation due to a disability, please contact People@taihooncology.com.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Research, Analyst, and Information Technology
Pharmaceutical Manufacturing
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