Job Title: Medical Director Pharmacovigilance, Rare Disease & PDT
Location: Boston, Massachusetts
Job Level: Senior
Travel: Minimal (up to 10%)
Remote Work: Up to 100% remote work permitted
Overview:
Takeda has been a leader in turning science into breakthrough medicines for over 240 years. Join a team that has been behind innovative therapies, making a meaningful impact on the lives of millions of patients worldwide. At Takeda, you will have the opportunity to shape the future of transformative therapies.
Job ID: R0148532
Date posted: 04/04/2025
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Job Description
Objective:
Serve as the Global Safety Lead (GSL) and patient safety expert for assigned pharmaceutical/biological/drug-device products.
Accountable for safety strategy and deliverables for each assigned product.
Lead the GPSE Safety Team (GST) and Safety Management Team (SMT).
Represent the cross-functional program team as a safety and risk mitigation expert.
Responsibilities:
Analyze and interpret safety data from various sources, including clinical trials, post-marketing data, and scientific literature.
Conduct signal detection, monitoring, and evaluation for assigned products.
Develop strategies and lead responses to safety-related inquiries from regulatory agencies.
Provide medical safety expertise for critical documents such as protocols, clinical research reports, and regulatory submissions.
Provide patient safety input to clinical development programs and represent GPSE on governance bodies.
Collaborate with other departments to address safety issues and ensure accurate safety information is included in company documents and labeling.
Requirements:
Doctorate in Medicine with 5 years of relevant experience.
Experience with Oracle Empirica for signal detection, safety data analysis, and trend identification.
Expertise in utilizing MedDRA for adverse event reporting and statistical methodologies for risk management.
Experience with periodic safety reports, risk management plans, and training of Pharmacovigilance associates.
Compensation and Benefits:
Salary: $222,600 - $381,600 per year, based on experience.
Competitive benefits package.
Locations:
Boston, MA (Remote work permitted)
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full-time
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