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Medical Director Pharmacovigilance, Rare Disease & Pdt

5+ years
$222,600-$381,600 per year
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

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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