Senior Principal Pharmacovigilance Scientist, Gastrointestinal and Inflammation

Takeda; Boston (MA); Remote; USD 137,000 - 216,000; Full time

Job summary

Join a leading pharmaceutical company as a Senior Principal Pharmacovigilance Scientist, focusing on gastrointestinal and inflammation areas. This role involves managing safety data, collaborating with global teams, and ensuring compliance in pharmacovigilance activities. The position offers career development, comprehensive health benefits, and flexible work arrangements.

Benefits

Career development opportunities

Comprehensive health benefits

Retirement plans

Wellness programs

Flexible work arrangements

Community and family support programs

Qualifications

• Minimum 6 years of related experience in pharmacovigilance.
• Proficiency in safety databases and data analysis.
• Strong communication and critical thinking skills.

Responsibilities

• Perform pharmacovigilance activities including case review and safety data analysis.
• Coordinate with global teams for compliance and safety data management.
• Lead safety procedures and contribute to safety documentation.

Skills

Safety signal detection

Safety reporting

Clinical trial methodology

Regulatory knowledge

Data analysis

Communication

Decision-making

Critical thinking

Education

Bachelor's degree

Advanced degree (MD, Ph.D., PharmD)

Tools

Safety databases

MedDRA coding

Job description

Senior Principal Pharmacovigilance Scientist, Gastrointestinal and Inflammation

Join Takeda as a Senior Principal Pharmacovigilance Scientist, Gastrointestinal and Inflammation. This role involves providing pharmacovigilance expertise, managing operational activities, and representing the department in global teams. Responsibilities include signal detection, safety monitoring, review of safety data, and regulatory responses. The position reports to the Senior Medical Director, GI, and requires collaboration with cross-functional teams.

Key Responsibilities:

• Perform pharmacovigilance activities including case review, reportability assessments, and safety data analysis.
• Coordinate with global teams to ensure compliance and efficient safety data management.
• Represent pharmacovigilance in cross-functional and external meetings.
• Lead safety procedures for developmental programs and contribute to safety documentation.
• Participate in signal detection, safety reviews, and regulatory safety responses.
• Communicate complex safety data clearly to diverse audiences, including leading presentations.

Minimum Qualifications:

• Bachelor's degree required; advanced degree or pharmacovigilance qualification preferred (MD, Ph.D., PharmD).
• At least 6 years of related experience, including safety signal detection, safety reporting, clinical trial methodology, and regulatory knowledge.
• Proficiency in safety databases, MedDRA coding, and data analysis.
• Strong communication, decision-making, and critical thinking skills.

What Takeda Offers:

• Career development opportunities
• Comprehensive health benefits
• Retirement plans and wellness programs
• Flexible work arrangements
• Community and family support programs

About Takeda: We are a global leader in innovative pharmaceuticals committed to transforming patient care. We value diversity, foster collaboration, and aim to deliver better health outcomes worldwide.

This position is remote, based in Massachusetts, with a salary range of $137,000 to $215,270 annually, depending on experience and qualifications.