[Hiring] Medical Director Pharmacovigilance, Rare Disease & PDT @Takeda
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Role Description
Takeda Development Center Americas, Inc. is seeking a Medical Director Pharmacovigilance, Rare Disease & PDT with the following duties:
ā¢ Serve as Global Safety Lead (GSL) and the Company-wide patient safety expert for assigned pharmaceutical/biological/drug device combined products.
ā¢ Accountable for the safety strategy and major safety deliverables for each assigned product.
ā¢ Lead GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products.
ā¢ Represent the cross-functional program team as a product safety profile and risk mitigation expert for internal and external stakeholders.
ā¢ Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing, and scientific literature for assessment of benefit-risk profile.
ā¢ Conduct signal detection, monitoring, evaluation, interpretation, and management for assigned compounds and products.
ā¢ Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees.
ā¢ Provide medical safety expertise, medical interpretation, review, and authorship of appropriate sections for critical documents.
ā¢ Provide patient safety input to the clinical development program for assigned products and development compounds.
ā¢ Collaborate and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
ā¢ Ensure up-to-date representation of safety information in Company Core Data Sheet and other labeling documents.
ā¢ Up to 10% domestic travel to attend internal meetings.
ā¢ Up to 100% remote work permitted.
Qualifications
ā¢ Doctor of Medicine (M.D.) plus 5 years of related experience.
Requirements
ā¢ Utilize Oracle Empirica for routine signal detection activities and analyze safety data.
ā¢ Identify trends and detect new or emerging safety signals from various data sources.
ā¢ Analyze using statistical methodologies (e.g., disproportionality analysis) within Empirica.
ā¢ Evaluate and develop periodic safety reports including Periodic Benefit Risk Evaluation Reports.
ā¢ Utilize MedDRA and assign appropriate MedDRA terms to describe adverse events.
ā¢ Design and implement strategic, operational and personnel development plans for assigned Pharmacovigilance associates.
Benefits
ā¢ Full time position.
ā¢ Salary range: $222,600 - $381,600 per year.
Apply tot his job
Apply To this Job
Role Description
Takeda Development Center Americas, Inc. is seeking a Medical Director Pharmacovigilance, Rare Disease & PDT with the following duties:
ā¢ Serve as Global Safety Lead (GSL) and the Company-wide patient safety expert for assigned pharmaceutical/biological/drug device combined products.
ā¢ Accountable for the safety strategy and major safety deliverables for each assigned product.
ā¢ Lead GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products.
ā¢ Represent the cross-functional program team as a product safety profile and risk mitigation expert for internal and external stakeholders.
ā¢ Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing, and scientific literature for assessment of benefit-risk profile.
ā¢ Conduct signal detection, monitoring, evaluation, interpretation, and management for assigned compounds and products.
ā¢ Develop strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees.
ā¢ Provide medical safety expertise, medical interpretation, review, and authorship of appropriate sections for critical documents.
ā¢ Provide patient safety input to the clinical development program for assigned products and development compounds.
ā¢ Collaborate and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
ā¢ Ensure up-to-date representation of safety information in Company Core Data Sheet and other labeling documents.
ā¢ Up to 10% domestic travel to attend internal meetings.
ā¢ Up to 100% remote work permitted.
Qualifications
ā¢ Doctor of Medicine (M.D.) plus 5 years of related experience.
Requirements
ā¢ Utilize Oracle Empirica for routine signal detection activities and analyze safety data.
ā¢ Identify trends and detect new or emerging safety signals from various data sources.
ā¢ Analyze using statistical methodologies (e.g., disproportionality analysis) within Empirica.
ā¢ Evaluate and develop periodic safety reports including Periodic Benefit Risk Evaluation Reports.
ā¢ Utilize MedDRA and assign appropriate MedDRA terms to describe adverse events.
ā¢ Design and implement strategic, operational and personnel development plans for assigned Pharmacovigilance associates.
Benefits
ā¢ Full time position.
ā¢ Salary range: $222,600 - $381,600 per year.
Apply tot his job
Apply To this Job