- Lead aggregate reports for assigned products
- Support Medical Surveillance Physicians in benefit-risk assessment
- Collaborate on signal management and risk minimization activities
- Develop Risk Management Plans and associated activities
- Participate in study initiation and review processes
- Evaluate and enhance medical surveillance processes
- Ensure compliance with regulatory requirements
- Participate in audit preparedness and inspections
- Manage relationships with internal and external stakeholders
- Oversee training of pharmacovigilance vendors
- Contribute to PV Sciences as needed
- Excellent communication and interpersonal skills
- Ability to work independently and collaboratively
- Strong organizational and time management abilities
- Capacity to influence and drive results
- Analytical and problem-solving skills
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Associate Director, PV Sciences - Princeton, United States - TAIHO ONCOLOGY INC
Description
Taiho Oncology - Associate Director, PV Sciences
Are you ready to contribute to the field of oncology in a meaningful way? Taiho Oncology is committed to enhancing the lives of cancer patients, their loved ones, and caregivers. With a 'People first' approach, we prioritize the well-being of our employees who play a crucial role in fulfilling our mission. Our core values of accountability, collaboration, and trust guide our actions and help us build trust with patients, healthcare professionals, partners, and each other.
Join us in our innovative journey where cutting-edge science, a top-notch clinical development team, and modern facilities enable us to make a difference in the lives of countless patients. Taiho Oncology invites you to be a part of our legacy and make your mark in the field.
Employee Value Proposition:
Embark on an exciting career as an Associate Director in PV Sciences at Taiho Oncology. Dive into the world of pharmacovigilance innovation, where your expertise and leadership will drive significant outcomes. Make an impact by shaping the future of drug safety, contributing to groundbreaking research, and advancing global patient care.
We offer competitive compensation, comprehensive benefits, and a supportive environment that fosters personal and professional growth. Join us in our mission and be a key player in the evolution of Taiho, leveraging your experience to drive progress in our dynamic organization.
Position Summary:
The Associate Director, PV Sciences will oversee medical surveillance activities and lead the Pharmacovigilance Sciences function within the PV department. This role involves managing PV activities for specific products in coordination with the Medical Surveillance Physician and collaborating with internal and external stakeholders on pharmacovigilance-related issues.
Performance Objectives:
Education/Certification Requirements:
Bachelor's degree in a healthcare-related field or equivalent. Prior experience in pharmacovigilance within the pharmaceutical industry. Knowledge of FDA, EU, and ICH guidelines. Familiarity with MedDRA terminology. Demonstrated ability to improve processes and ensure regulatory compliance.
Knowledge, Skills, and Abilities:
This position offers a starting salary range of $181,050 to $213,000 annually, with additional benefits including sign-on bonuses, medical coverage, retirement plans, and more. Join Taiho Oncology in making a difference and shaping the future of cancer care.
Equal Opportunity Employer Information:
Taiho Oncology is proud to be an Equal Opportunity Employer. We welcome applications from individuals of all backgrounds without regard to race, gender, age, religion, disability, or any other protected status. Accommodations are available for applicants with disabilities during the recruitment process.
As part of our commitment to diversity, we consider qualified candidates with previous arrest or conviction records, in accordance with Fair Chance Laws and Ordinances. The incumbent in this role may be assigned additional duties as needed.
