Global Medical Review Director

USA - 3316 Takeda Development Center Americas, Inc.; Cambridge (MA); Hybride; USD 212 000 - 333 000; Plein temps

Résumé du poste

Takeda in Cambridge, MA is seeking a Senior Director, Head of Medical Review to lead global medical assessment of individual case safety reports across therapies. Hybrid work with international collaboration; lead a team of medical review physicians and oversee outsourced activities.

This role ensures compliance with ICH/GCP and FDA/EMA/MHRA requirements, drives SOPs, CAPA, and continuous process improvements.

Qualifications

• Medical degree required; governance over global pharmacovigilance.
• 15+ years of pharmaceutical or healthcare industry experience.
• 3 years clinical experience post-graduate training.
• 15+ years pharmacovigilance including medical review of individual case safety reports.
• Strong working knowledge of US/EU/MHRA drug safety regulations, CIOMS and ICH guidelines.
• Experience leading matrix teams and cross-functional collaboration.
• Global/international experience required.

Responsabilités

• Provide strategic leadership and oversight for medical review and case assessment activities.
• Oversee medical assessment of individual case safety reports in the Global Safety Database.
• Lead and provide medical oversight for outsourced medical review activities.
• Ensure medical assessment meets highest standards and regulatory compliance.
• Develop, author, maintain procedural documents and training materials.
• Collaborate with LOCs/DSOs and cross-functional stakeholders on medical review.
• Support inspections and CAPA related to medical review and case assessment.
• Keep management informed of safety concerns and evolving risks.

Connaissances

Strategic leadership

People leadership

Global/international experience

Regulatory knowledge

Formation

Medical degree

Description du poste

Takeda in Cambridge, MA is seeking a Senior Director, Head of Medical Review to lead global medical assessment of individual case safety reports across therapies. Hybrid work with international collaboration; lead a team of medical review physicians and oversee outsourced activities.

This role ensures compliance with ICH/GCP and FDA/EMA/MHRA requirements, drives SOPs, CAPA, and continuous process improvements.