Senior Principal Pharmacovigilance Scientist – Strategic Safety

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

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.