Head, Medical Safety Sciences, Patient Safety & Pharmacovigilance (PSPV) (Vice President)

Takeda Pharmaceutical Company - Cambridge, MA

Full-time - Senior

Cambridge, MA

Chemical Manufacturing

About the position

The position is responsible for optimizing the detection of safety signals and assessing the benefit-risk profile for products in clinical development and marketed from the Takeda portfolio. This role involves applying expertise in Signal Management, Risk Management, Medical Review, and Aggregate Safety Reports while ensuring compliance with global Pharmacovigilance regulations. The individual will lead cross-functional collaborations, oversee the Risk Management Center of Excellence, and ensure adherence to regulatory requirements, all while advocating for the vision and mission of Global Patient Safety & Pharmacovigilance (PSPV).

Responsibilities

• Lead and ensure managerial oversight of PSPV functions for safety signal detection and benefit-risk assessment.
• Support and advocate the vision and mission of Global Patient Safety & Pharmacovigilance as a member of the leadership team.
• Establish cross-functional collaborations across PSPV and R&D.
• Oversee the PV Risk Management Center of Excellence and ensure operational excellence.
• Provide leadership in benefit-risk assessments and risk management plans.
• Develop comprehensive benefit-risk analyses using qualitative and quantitative methodologies.
• Lead patient engagement activities and manage the Orbit risk management tracking tool.
• Establish a robust Signal Management process and advance the use of digitalization and AI in safety analytics.
• Ensure compliance with regulatory authorities in all processes and procedures.
• Consolidate data into comprehensive safety reports for regulatory authorities.

Requirements

• Bachelor's degree required; advanced degree (MD, PhD, or PharmD) preferred.
• Minimum 15 years of experience in the pharmaceutical industry.
• Advanced knowledge of Pharmacovigilance and global regulations.
• Experience in a multi-disciplinary environment and international settings.
• Proven leadership experience in managing large, globally dispersed teams.
• Strong communication skills and ability to influence stakeholders.

Nice-to-haves

• Experience in business process transformation and organizational culture change.
• Health care business acumen with a comprehensive understanding of the pharmaceutical industry.

Benefits

• Medical, dental, and vision insurance coverage.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays and well-being benefits.
• Sick time and paid vacation accrual.