Global Safety Lead – Rare Disease & PDT (Remote)

Regulatory Jobs; Boston (MA); Remote; USD 302,000 - 373,000; Full time

Job summary

Takeda Development Center Americas, Inc. is seeking a Medical Director of Pharmacovigilance, Rare Disease & PDT to lead safety strategy and major safety deliverables for assigned products. You will guide cross-functional teams, manage safety data, and oversee safety documentation.

The role requires an MD with 5+ years in pharmacovigilance, proficiency in Oracle Empirica, MedDRA coding, and risk management planning. Up to 10% travel, with up to 100% remote work allowed in the U.S.

Qualifications

• MD required with 5+ years in pharmacovigilance.
• Experience using Oracle Empirica for signal detection and safety data analysis.
• Experience with MedDRA coding and WHO DD dictionary.
• Ability to develop risk management plans and periodic safety reports.

Responsibilities

• Serve as Global Safety Lead and safety expert for assigned products.
• Lead GPSE Safety Team and Safety Management Team for projects.
• Prepare safety sections for regulatory submissions and critical documents.
• Collaborate with Clinical Development, Regulatory, Quality, Medical Affairs, and Legal.

Skills

Global Safety Lead

Pharmacovigilance

Signal detection

Oracle Empirica

Statistical analysis

MedDRA

Regulatory strategy

Education

Doctor of Medicine (MD)

Tools

Oracle Empirica

MedDRA

WHO DD dictionary

Job description

Takeda Development Center Americas, Inc. is seeking a Medical Director of Pharmacovigilance, Rare Disease & PDT to lead safety strategy and major safety deliverables for assigned products. You will guide cross-functional teams, manage safety data, and oversee safety documentation.

The role requires an MD with 5+ years in pharmacovigilance, proficiency in Oracle Empirica, MedDRA coding, and risk management planning. Up to 10% travel, with up to 100% remote work allowed in the U.S.