Medical Director Pharmacovigilance, Rare Disease & Pdt

Takeda Pharmaceutical

5+ years

$222,600-$381,600 per year

Boston

10 April 28, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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

By clicking the “Apply” button, you acknowledge that the application process will commence, and 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 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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Medical Director Pharmacovigilance, Rare Disease & Pdt

Job Description

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