Senior Principal Pharmacovigilance Scientist

Takeda•Boston, MA

4d•$137,000 - $215,270

About The Position

The Senior Principal Pharmacovigilance Scientist ensures regulatory compliance and the safety of Takeda's products by managing large projects, developing innovative solutions, and leading teams. The role contributes to the development and execution of pharmacovigilance strategies to protect patient safety and support regulatory adherence. As an expert professional, the position develops innovative solutions to complex problems aligned with organizational objectives. The work involves intricate issues requiring in-depth analysis and judgment, collaboration with key contacts outside the area of expertise, and contributions to new concepts and standards. Operating with considerable autonomy, the scientist serves as a consultant to management and an external spokesperson on major matters, often working independently and leading functional teams or projects. The role also includes training and mentoring junior staff.

Requirements

Comprehensive risk management expertise in complex situations, including the ability to advise others.
Recognized expertise in pharmacovigilance, including the ability to develop strategic safety initiatives and coach others.
Deep understanding of safety regulations and guidelines to ensure regulatory compliance.
Proficiency in safety reporting and the ability to lead preparation of detailed reports.
Ability to independently conduct signal detection and safety assessments and provide critical analysis.
Experience in clinical development.
Ability to engage effectively with stakeholders and regulatory authorities and provide authoritative advice.
Ability to lead teams, foster collaboration, and mentor junior staff.
Ability to deliver pharmacovigilance training.
Strong communication, analytical, and decision-making skills, including in high-stakes environments.

Responsibilities

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 and foster a collaborative environment.
Deliver training on pharmacovigilance practices to enhance team capabilities.
Contribute to the strategic planning and execution of clinical trials.
Communicate complex safety data clearly and effectively to various audiences.
Analyze safety data to support informed decisions.
Serve as a consultant to management and an external spokesperson on major matters.