Associate Director PV Sciences
Associate Director PV Sciences
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$ 193000 - 227000
1 Vacancy
Job Description
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. Taihos 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 cuttingedge 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 worldclass clinical development organization and stateoftheart facilities: these and other resources empower us to innovate and touch the lives of more and more patients. Its 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 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. As an integral part of our team youll 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 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 crossfunctionally with key internal and external key leaders and external resources on pharmacovigilancerelated matters.
Performance Objectives:
Responsibilities and Duties:
- Lead aggregate reports (e.g. DSUR PBRER topic reports) for assigned products.
- Responsible for supporting Medical Surveillance Physicians towards product benefitrisk assessment and related activities of assigned product/s.
- Responsible for collaborating with Medical Surveillance Physicians towards adhoc and routine Global Safety Management Team (GSMT) meetings.
- Lead signal management activities in collaboration with the Medical Surveillance team.
- Lead development/maintenance of Risk Management Plans (RMP) and associated pharmacovigilance and risk minimization activities for assigned products.
- Participate in new study initiation to ensure PV requirements are met including but not limited to safety reporting query resolution SAE reconciliation unblinding process and safety reporting training.
- Participate in the review of protocols informed consents Company Core Data Sheets Investigator Brochures clinical summary of the NDA/MAA and product labeling and other applicable documents for clinical trials.
- Evaluate current processes and escalate as needed to enhance medical surveillance and risk management process towards continuous improvement and to ensure best practices.
- Oversee and manage review and approval of the Safety Reporting Plans as applicable.
- Develop or update Standard Operating Procedures Working Instructions and training materials for applicable tasks as needed.
- Collaborate with internal and external stakeholders outside of Taiho (such as Business partners).
- Effectively manage to ensure compliance with regulatory submissions and internal timelines.
- Participate in audit preparedness activities and serves as subject matter expert during regulatory inspections in collaboration with team members.
- Maintain training and oversight to clinical operations/pharmacovigilance vendors supporting pharmacovigilance activities as needed.
- Other supporting activities on behalf of PV Sciences as needed or as requested by supervisor.
- This role may have direct reports (other PV Scientists or consultants as applicable).
Education/Certification Requirements:
- Bachelors degree in healthcare related discipline or equivalent. RN R.Ph. or Pharm D. degree is highly preferred.
- Minimum of 810 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 crossfunctional team is a plus.
- Expertise in relevant food and drug administration (FDA) European union (EU) and international conference on Harmonization (ICH) guidelines initiatives and regulations governing pharmacovigilance.
- Extensive working knowledge of medical terminology and medical dictionary of regulatory activities (MedDRA).
- Demonstrated handson experience identifying developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality.
Knowledge Skills and Abilities:
- Excellent verbal and written communication and skills.
- Ability to work independently and collaboratively as required in a fastpaced matrixed team environment consisting of internal and external team members.
- Excellent planning organization and time management skills including the ability to support and prioritize multiple projects.
- Ability to influence without direct authority.
- Ability to read analyze and interpret professional journals technical procedures and governmental regulations.
- Ability to write reports business correspondence and procedures.
- Ability to effectively present information and respond to questions from internal and external clients both domestic and international.
- Ability to work with mathematical concepts such as probability and statistical inference.
- Ability to apply concepts such as fractions percentages ratios and proportions to practical situations.
- Analytical thinker with excellent problemsolving skills and the ability to adapt to changing priorities and deadlines.
The pay range for this position at commencement of employment is expected to be between $193000 $227000 annually. This pay range is based on the market range for positions of this type. However base pay offered may vary depending on multiple individualized factors including market location jobrelated knowledge skills and experience. The total compensation package for this position may also include other elements including a signon bonus restricted stock units commissions and discretionary awards in addition to a full range of medical financial and/or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired employee will be in an atwill position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.
#LocationPrincetonNJ#LIHybrid
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 sex age religion creed national origin ancestry citizenship marital status sexual orientation physical or mental disability medical condition veteran status gender identity genetic information or any other characteristic protected by federal state or local law. Any applicant who because of a disability needs an accommodation or assistance in completing an application or at any time during the application process please email . Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances we will consider for employment qualified applicants with arrest and conviction records.
The incumbent in this position may be required to perform other duties as assigned.
Other details
- Job FamilyR&D
- Job FunctionPharmacovigilance
Required Experience:
Director
Employment Type
Full-Time
