Senior Principal Pharmacovigilance Scientist

Takeda•Cambridge, MA

23d•$137,000 - $215,270•Onsite

About The Position

The Pharmacovigilance Scientist, Senior 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.

Requirements

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

Nice To Haves

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.

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, fostering a collaborative environment
Deliver training on pharmacovigilance practices to enhance team capabilities