Medical Director Pharmacovigilance, Rare Disease & PDT

About the position Takeda Development Center Americas, Inc. is seeking a Medical Director Pharmacovigilance, Rare Disease & PDT with the following duties: Serve as Global Safety Lead (GSL) and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety strategy and major safety deliverables for each assigned product; lead GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products and represents the cross-functional program team as a product safety profile and risk mitigation expert for internal (e.g., Takeda Safety Board) and external (e.g., Independent Data Monitoring Committee) stakeholders; analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing and scientific literature for assessment of benefit-risk profile and updating of the benefit-risk documents, e.g., RMPs, for assigned compounds and products; conduct signal detection, monitoring, evaluation, interpretation, and management for assigned compounds and products; develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees, MAAs, NDAs, and BLAs; provide medical safety expertise, medical interpretation, review, and authorship of appropriate sections for critical documents (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, Health Hazard Evaluations, Signal Evaluation Reports, INDs, NDAs, BLAs, and CTAs) in collaboration with cross-functional colleagues; provide patient safety input to the clinical development program for assigned products and development compounds, and represent GPSE on internal governance bodies for study protocols, statistical analysis plans and other clinical study-related documents as applicable; collaborate and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal; ensure up-to-date representation of safety information in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents. Up to 10% domestic travel required. Up to 100% remote work permitted.

Responsibilities

• Serve as Global Safety Lead (GSL) and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products.
• Lead GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products.
• Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing and scientific literature.
• Conduct signal detection, monitoring, evaluation, interpretation, and management for assigned compounds and products.
• Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees.
• Provide medical safety expertise, medical interpretation, review, and authorship of appropriate sections for critical documents.
• Provide patient safety input to the clinical development program for assigned products and development compounds.
• Collaborate and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
• Ensure up-to-date representation of safety information in Company Core Data Sheet and Investigator Brochure.

Requirements

• Doctorate in Medicine plus 5 years of related experience.
• Prior experience must include utilizing Oracle Empirica for routine signal detection activities and analyzing safety data.
• Identify trends and detect new or emerging safety signals from various data sources such as spontaneous adverse event reports, clinical trial data, and literature.
• Analyze using statistical methodologies (e.g., disproportionality analysis) within Empirica to assess potential safety concerns.
• Evaluate and develop periodic safety reports including Periodic Benefit Risk Evaluation Reports, Developmental Safety Update Reports, and Periodic Adverse Drug Experience Reports.
• Utilize MedDRA and assign appropriate MedDRA terms to describe adverse events and WHO DD dictionary coding.
• Design and implementation of strategic, operational and personnel development plans as well as training curriculum for assigned Pharmacovigilance associates and specialists.

Benefits

• Competitive compensation and benefits.

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