Senior Principal Pharmacovigilance Scientist

Takeda; Boston (MA); On-site; USD 137,000 - 215,000; Full time

Job summary

Takeda is seeking a Senior Principal Pharmacovigilance Scientist to ensure regulatory compliance and product safety by managing large projects and leading teams. The role develops pharmacovigilance strategies, oversees risk management, and ensures patient safety alongside regulatory adherence.

The position involves managing complex PV projects, leading detailed safety reporting, performing signal detection, and mentoring junior staff while liaising with regulators and stakeholders.

Qualifications

• Ability to apply comprehensive risk management strategies in complex situations
• Recognized expert in pharmacovigilance with capability to develop strategic safety initiatives
• Strong understanding of safety regulations and guidelines
• Proficiency in safety reporting and lead preparation of detailed reports
• Experience in clinical development contributing to strategic planning and execution of clinical trials
• Excellent stakeholder engagement with regulatory authorities and cross-functional teams
• Ability to mentor and coach junior staff and deliver training on pharmacovigilance
• Clear and effective communication of complex safety data to diverse audiences
• Analytical and decisive in high-stakes environments

Responsibilities

• Manage large pharmacovigilance projects or processes with limited oversight
• Develop and implement risk management strategies for complex situations
• Lead preparation and review of detailed safety reports
• Conduct signal detection and safety assessments independently
• Engage with stakeholders and regulatory authorities, providing authoritative advice
• Lead and mentor junior staff, fostering a collaborative environment
• Deliver training on pharmacovigilance practices to enhance team capabilities

Job description

Job Description

About the role:

The Senior Principal Pharmacovigilance Scientist ensures regulatory compliance and safety of Takeda's products by managing large projects, developing innovative solutions, and leading teams. This role contributes to the development and execution of pharmacovigilance strategies, ensuring patient safety and regulatory adherence.

How you will contribute:

• Manage large pharmacovigilance projects or processes with limited oversight
• Develop and implement risk management strategies for complex situations
• Lead the preparation and review of detailed safety reports
• Conduct signal detection and safety assessments independently
• Engage with stakeholders and regulatory authorities, providing authoritative advice
• Lead and mentor junior staff, fostering a collaborative environment
• Deliver training on pharmacovigilance practices to enhance team capabilities

Skills and qualifications:

• Applies comprehensive risk management strategies in complex situations, capable of advising others
• Recognized as an expert in pharmacovigilance, able to develop strategic safety initiatives and coach others
• Ensures regulatory compliance with a deep understanding of safety regulations and guidelines
• Proficient in safety reporting and able to lead the preparation of detailed reports
• Conducts signal detection and safety assessments independently, providing critical analysis
• Experienced in clinical development, contributing to the strategic planning and execution of clinical trials
• Engages effectively with stakeholders and regulatory authorities, providing authoritative advice
• Leads teams effectively, fostering a collaborative environment and mentoring junior staff
• Delivers training on pharmacovigilance practices, enhancing team capabilities
• Communicates complex safety data clearly and effectively to various audiences
• Analyzes safety data meticulously to make informed decisions
• Demonstrates strong decision-making skills in high-stake environments

As an expert professional within the organization, you develop innovative solutions to complex problems aligned with organizational objectives. Your work involves addressing intricate issues, requiring in-depth analysis and judgment. You also engage with key contacts outside your expertise area and contribute to the development of new concepts and standards. Operating with considerable autonomy, you serve as a consultant to management and an external spokesperson on major matters, often working independently and leading function teams or projects. Additionally, you play a role in training and mentoring junior staff.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Boston, MA

U.S. Base Salary Range:

$137,000.00 - $215,270.00

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.