Overview
Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary
The Director, Drug Safety Physician
is the Lead of the Global Safety Team(s) to develop safety strategies to ensure patient safety and regulatory compliance for products in development and/or marketed. The Director is responsible for medical analysis of safety data, validation and confirmation of safety signals, and implementation of processes for communication and management of emerging signals and safety data to internal and external stakeholders. The role contributes to the continuous improvement of the Kyowa Kirin Pharmacovigilance System to align the global PV strategy with regulatory requirements and business needs. Responsibilities Lead Global Safety Team(s) to ensure high-quality, accurate, and timely medical contributions to the safety evaluation of Kyowa Kirin products, including identifying and implementing safety strategies to deliver company targets for products in development and the market.
Determine safety strategy for global regulatory submissions (e.g., North America, EMEA/ROW, Japan, Asia Pacific) and ensure delivery of high-quality safety documentation for those submissions.
Lead/develop strategies for safety-related regulatory activities and support interpretation and authoring of safety sections of documents (protocols, ICFs, IBs, CSRs, CCSI, DSURs, PSUR, PADER, REMS, DMC reports, etc.) in collaboration with the PV Scientist.
Lead the preparation of Benefit Risk Assessments for Kyowa Kirin products and support implementation of conclusions.
Develop proactive risk management strategies for marketed or investigational compounds and ensure these are contained and implemented in appropriate strategies (e.g., Risk Management Plans) with cross-functional liaison to Global Development, Franchise, and labeling teams.
Lead signal detection activities using data from all sources and drive Benefit Risk assessment reports, support of Company Core Data Sheets, and related actions.
Provide medical review and interpretation of safety data for aggregate reports and ensure consistent messaging across development and post-marketing communications.
Contribute to the preparation and review of pharmacovigilance documentation by providing medical expertise for responses to internal and external questions regarding safe use of Kyowa Kirin products and safety issue workups.
Ensure updated safety profiles are provided to senior management as required.
Represent Pharmacovigilance at internal and external meetings and present the Global Safety Team’s safety recommendations to cross-functional decision-making bodies and teams (e.g., PV, R&D, Evidence Generation, Label, Global Development, Franchise).
Maintain awareness of regulatory guidance updates and pharmacovigilance processes; recommend improvements to the department’s effectiveness.
Participate in due diligence as requested, with clear recommendations for progression to agreement.
Ensure Ethics and Medical Compliance in all pharmacovigilance activities and work cross-functionally within project teams to meet company objectives.
Any other activity reasonably required.
Requirements
Education Medically qualified physician with post‑registration clinical experience. Completed specialist training and/or clinical exposure in immunology and/or haemato‑oncology is strongly preferred. Experience Minimum of eight (8) years’ experience in pharmacovigilance or a related area of clinical development in biotechnology or pharmaceutical industry. Demonstrated in-depth knowledge of global pharmacovigilance regulatory requirements, including pre-approval and post-marketing environments. Technical Skills Proficient in MS Office Suite. Experience in the use and management of Drug Safety Databases and MedDRA coding. Working Conditions Requires up to 10% domestic and international travel. Compensation & Benefits
The anticipated salary for this position will be
$250,000 to $275,000 . The actual salary offered may vary based on experience, skills, qualifications, education, licenses, location, and business needs. This salary is one component of the overall compensation package. Kyowa Kirin North America provides a comprehensive benefits program including:
401K with company match
Annual Bonus Program (Sales Bonus for Sales Jobs)
Generous PTO and Holiday Schedule (Summer and Winter Shutdowns, Sick Days, Volunteer Days)
Healthcare Benefits (Medical, Dental, Prescription Drugs, Vision)
Well-Being and Work/Life Programs
Life & Disability Insurance
Long Term Incentive Program (subject to job level and performance)
Pet Insurance
Tuition Assistance
Employee Referral Awards
The compensation and benefits information apply to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits per local market. Equal Employment Opportunity
Kyowa Kirin North America does not discriminate on the basis of protected status. We comply with applicable equal employment opportunity laws and policies.
Data privacy notice: The personal data collected in connection with the recruitment process may be stored and processed as described in our privacy policy. By applying, you consent to the processing of your information for recruitment purposes.
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Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary
The Director, Drug Safety Physician
is the Lead of the Global Safety Team(s) to develop safety strategies to ensure patient safety and regulatory compliance for products in development and/or marketed. The Director is responsible for medical analysis of safety data, validation and confirmation of safety signals, and implementation of processes for communication and management of emerging signals and safety data to internal and external stakeholders. The role contributes to the continuous improvement of the Kyowa Kirin Pharmacovigilance System to align the global PV strategy with regulatory requirements and business needs. Responsibilities Lead Global Safety Team(s) to ensure high-quality, accurate, and timely medical contributions to the safety evaluation of Kyowa Kirin products, including identifying and implementing safety strategies to deliver company targets for products in development and the market.
Determine safety strategy for global regulatory submissions (e.g., North America, EMEA/ROW, Japan, Asia Pacific) and ensure delivery of high-quality safety documentation for those submissions.
Lead/develop strategies for safety-related regulatory activities and support interpretation and authoring of safety sections of documents (protocols, ICFs, IBs, CSRs, CCSI, DSURs, PSUR, PADER, REMS, DMC reports, etc.) in collaboration with the PV Scientist.
Lead the preparation of Benefit Risk Assessments for Kyowa Kirin products and support implementation of conclusions.
Develop proactive risk management strategies for marketed or investigational compounds and ensure these are contained and implemented in appropriate strategies (e.g., Risk Management Plans) with cross-functional liaison to Global Development, Franchise, and labeling teams.
Lead signal detection activities using data from all sources and drive Benefit Risk assessment reports, support of Company Core Data Sheets, and related actions.
Provide medical review and interpretation of safety data for aggregate reports and ensure consistent messaging across development and post-marketing communications.
Contribute to the preparation and review of pharmacovigilance documentation by providing medical expertise for responses to internal and external questions regarding safe use of Kyowa Kirin products and safety issue workups.
Ensure updated safety profiles are provided to senior management as required.
Represent Pharmacovigilance at internal and external meetings and present the Global Safety Team’s safety recommendations to cross-functional decision-making bodies and teams (e.g., PV, R&D, Evidence Generation, Label, Global Development, Franchise).
Maintain awareness of regulatory guidance updates and pharmacovigilance processes; recommend improvements to the department’s effectiveness.
Participate in due diligence as requested, with clear recommendations for progression to agreement.
Ensure Ethics and Medical Compliance in all pharmacovigilance activities and work cross-functionally within project teams to meet company objectives.
Any other activity reasonably required.
Requirements
Education Medically qualified physician with post‑registration clinical experience. Completed specialist training and/or clinical exposure in immunology and/or haemato‑oncology is strongly preferred. Experience Minimum of eight (8) years’ experience in pharmacovigilance or a related area of clinical development in biotechnology or pharmaceutical industry. Demonstrated in-depth knowledge of global pharmacovigilance regulatory requirements, including pre-approval and post-marketing environments. Technical Skills Proficient in MS Office Suite. Experience in the use and management of Drug Safety Databases and MedDRA coding. Working Conditions Requires up to 10% domestic and international travel. Compensation & Benefits
The anticipated salary for this position will be
$250,000 to $275,000 . The actual salary offered may vary based on experience, skills, qualifications, education, licenses, location, and business needs. This salary is one component of the overall compensation package. Kyowa Kirin North America provides a comprehensive benefits program including:
401K with company match
Annual Bonus Program (Sales Bonus for Sales Jobs)
Generous PTO and Holiday Schedule (Summer and Winter Shutdowns, Sick Days, Volunteer Days)
Healthcare Benefits (Medical, Dental, Prescription Drugs, Vision)
Well-Being and Work/Life Programs
Life & Disability Insurance
Long Term Incentive Program (subject to job level and performance)
Pet Insurance
Tuition Assistance
Employee Referral Awards
The compensation and benefits information apply to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits per local market. Equal Employment Opportunity
Kyowa Kirin North America does not discriminate on the basis of protected status. We comply with applicable equal employment opportunity laws and policies.
Data privacy notice: The personal data collected in connection with the recruitment process may be stored and processed as described in our privacy policy. By applying, you consent to the processing of your information for recruitment purposes.
#J-18808-Ljbffr