Job Title: Medical Director, Gastrointestinal & Inflammation/Neuroscience (Remote)
Location: Remote
Job Level: Senior
Travel: Minimal (if any)
Overview:
Takeda has a rich 240-year history of turning science into breakthrough medicines. Join a team dedicated to driving innovative therapies that make a lasting difference for millions of patients globally. At Takeda, your role will play a critical part in advancing transformative therapies while shaping your bright future.
Job ID: R0145500
Date posted: 02/24/2025
By clicking the “Apply” button, you acknowledge that the application process will begin and that your information will be processed in line with Takeda’s privacy policies. You also confirm that the information you submit is truthful.
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 major safety deliverables for each product.
Lead the GPSE Safety Team (GST) and Safety Management Team (SMT).
Represent the cross-functional program team as a product safety and risk mitigation expert.
Accountabilities:
Analyze and interpret safety data from various sources, including non-clinical, clinical, post-marketing, and scientific literature.
Conduct signal detection, monitoring, evaluation, and management for assigned products.
Develop safety strategies and respond to inquiries from regulatory agencies and ethics committees.
Provide medical safety expertise, review, and author sections of critical documents (e.g., protocols, INDs, NDAs, etc.).
Collaborate with various functional areas to address safety issues.
Manage benefit-risk profile and collaborate with regulatory authorities on submissions.
Ensure accurate safety information representation in company documents and labeling.
Mentor Pharmacovigilance Physicians and Specialists.
Qualifications:
M.D. or D.O. or internationally recognized equivalent, with clinical experience in patient care.
Board certification and licensure preferred.
Minimum 5 years of experience in pharmaceutical industry within Drug Safety/Pharmacovigilance.
Minimum 3 years of experience with aggregate reporting, safety surveillance, and risk management.
In-depth knowledge of national and international pharmacovigilance guidelines.
Compensation and Benefits:
U.S. Base Salary Range: $228,200 - $358,600
Actual salary may vary depending on qualifications, experience, and location.
Benefits include medical, dental, and vision insurance, 401(k) plan with company match, disability coverage, life insurance, paid time off, and more.
EEO Statement:
Takeda is committed to creating a diverse workforce and providing equal opportunities to all employees, regardless of race, color, religion, sex, sexual orientation, gender identity, disability, and other protected categories.
Locations:
Massachusetts - Virtual
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full-time
Job Exempt:
Yes
Travel Requirements:
Local and international travel may be required.
Gujarat :
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