Senior PV Strategist & Safety Lead

Takeda Pharmaceutical Co.; 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

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.