Senior Principal Pharmacovigilance Scientist

Scorpion Therapeutics; Cambridge (MA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical/dental/vision benefits

401(k) match

Tuition reimbursement

Paid time off & holidays

Sick time & vacation

Job summary

Takeda is seeking a Pharmacovigilance Scientist, Senior Scientist to ensure regulatory compliance and patient safety by managing large projects, developing strategies, and leading teams. You will develop and execute pharmacovigilance plans to meet regulatory standards and safety objectives.

Responsibilities include leading risk management, safety reporting, signal detection, and mentoring junior staff while collaborating with stakeholders and authorities.

Qualifications

• Advanced risk management expertise in complex situations; advise others.
• Expert in pharmacovigilance; develop strategic safety initiatives and coach others.
• Deep knowledge of safety regulations to ensure regulatory compliance.
• Proficient in safety reporting; lead detailed report preparation.
• Independent signal detection and safety assessment.
• Clinical development experience (clinical trials planning/execution).
• Clear communication of complex safety data.
• Meticulous safety data analysis and strong decision-making in high-stakes environments.

Responsibilities

• Manage large pharmacovigilance projects/processes with limited oversight
• Develop and implement risk management strategies
• Lead preparation and review of detailed safety reports
• Conduct signal detection and safety assessments independently
• Provide authoritative advice to stakeholders and regulatory authorities
• Lead and mentor junior staff; foster collaboration
• Deliver training on pharmacovigilance practices

Skills

Pharmacovigilance

Risk management

Safety reporting

Signal detection

Regulatory compliance

Clinical development

Communication

Leadership

Job description

About the Role

The Pharmacovigilance Scientist, Senior Scientist ensures regulatory compliance and safety of Takeda’s products by managing large projects, developing solutions, and leading teams. Develop and execute pharmacovigilance strategies to ensure patient safety and regulatory adherence.

How you will contribute

• Manage large pharmacovigilance projects/processes with limited oversight
• Develop and implement risk management strategies
• Lead preparation and review of detailed safety reports
• Conduct signal detection and safety assessments independently
• Provide authoritative advice to stakeholders and regulatory authorities
• Lead and mentor junior staff; foster collaboration
• Deliver training on pharmacovigilance practices

Skills and Qualifications

• Advanced risk management expertise in complex situations; advise others
• Expert in pharmacovigilance; develop strategic safety initiatives and coach others
• Deep knowledge of safety regulations to ensure regulatory compliance
• Proficient in safety reporting; lead detailed report preparation
• Independent signal detection and safety assessment
• Clinical development experience (clinical trials planning/execution)
• Clear communication of complex safety data
• Meticulous safety data analysis and strong decision-making in high-stakes environments

Benefits (as stated)

• Eligible for short-/long-term incentives and medical/dental/vision, 401(k) match, disability and life insurance, tuition reimbursement, paid time off, holidays, well-being benefits; up to 80 hours sick time and up to 120 hours vacation for new hires.