Senior Principal Pharmacovigilance Scientist

USA - 3316 Takeda Development Center Americas, Inc.; Cambridge (MA); On-site; USD 137,000 - 215,000; Full time

Job summary

Takeda Pharmaceutical Co. is seeking a Senior Principal Pharmacovigilance Scientist in Boston, MA to lead large safety projects and develop risk management strategies.

The role focuses on ensuring regulatory compliance and patient safety through expert analysis and cross-functional leadership. You will mentor teams, deliver pharmacovigilance training, and interact with regulators to provide authoritative safety input.

Qualifications

• Must have strong risk management experience in pharmacovigilance contexts.
• Expert-level knowledge of pharmacovigilance regulations and safety guidelines.
• Proficient in safety reporting and regulatory interactions.
• Able to conduct signal detection and safety assessments independently.
• Experience leading teams and mentoring junior staff.

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.

Skills

Risk management

Pharmacovigilance expert

Regulatory compliance

Safety reporting

Signal detection

Clinical development

Stakeholder engagement

Team leadership

Training

Safety data communication

Safety data analysis

Decision making

Job description

Job Description

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.

Compensation and Benefits

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.

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

Location: Boston, MA U.S.

Worker Type

Worker Type: Employee

Worker Sub-Type: Regular Time Type Full time

Job Exempt: Yes

Legal Notice

It 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.

Company Culture

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda‑ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Takeda is an equal opportunity employer.