Director, Drug Safety Physician

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 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 that are in development and / or marketed. The Director Drug Safety Physician 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 Director Drug Safety Physician contributes to the constant improvement of the Kyowa Kirin Pharmacovigilance System to ensure the global PV strategy is in alignment with regulatory requirements and business needs.

Essential Functions:

Ensure high quality accurate timely medical contributions to the safety evaluation of Kyowa Kirin products by leading Global Safety Team(s) to:
Ensure the safe development of new products and contributions of safety are delivered in a timely and effective manner to Development teams including the identification and implementation of safety strategies to deliver Company targets for products in both development and the market.
Determine the safety strategy for the preparation of global regulatory submissions for Marketing Authorization approvals (e.g. North America EMEA/ ROW Japan and Asia Pacific) and ensure the delivery of high-quality safety documentation for those submissions.
Lead/ develop strategies for safety-related regulatory activities and support interpretation and authoring (in collaboration with the PV Scientist) of safety sections of documents including protocols ICFs IBs clinical study reports (CSRs) Company Core Safety Information (CCSI) DSURs PSUR PBER PADERRMP REMS Data Monitoring Committees reports etc.
Lead the preparation of Benefit Risk Assessments for Kyowa Kirin products and provide appropriate support for implementation of the associated conclusions.
Develop proactive risk management strategies for marketed and / or investigational compounds ensuring that these are contained and implemented in appropriate strategies including Risk Management Plans. Ensure success of such activities by close liaison with cross- functional Global Development Franchise and labeling Teams.
Lead signal detection activities using data from all sources and bring medical expertise to drive Benefit Risk assessment reports support of Company Core Data Sheets and other similar reports and actions.
Provide medical review and interpretation of safety data for preparation of aggregate reports and ensure consistent messaging across all such reports and documents issued for both development and post-marketing purposes.
Contribute to the preparation and review of pharmacovigilance documentation for internal and external use by providing medical expertise to the preparation of responses to internal and external questions relating to the safe use of Kyowa Kirin products safety issue work up etc.
Ensure that updated safety profiles of Kyowa Kirin products are provided to senior management as required.
Represent Pharmacovigilance at internal and external meetings where issues of drug safety are to be or may be discussed and lead presentation of the Global Safety Teams recommendations on safety issues to cross- functional decision-making bodies and Teams (e.g. global PV Committee R&D Committee Evidence Generation Committee Label Committee Global Development Teams Franchise Teams etc).
Maintain awareness of changes to regulatory guidance documents requirements and state-or-the-art pharmacovigilance processes and make recommendations leading to the improvement of the effectiveness and profile of the department.
Participate when requested in due diligence ensuring clear recommendations for progression to agreement.
Ensure that Ethics and Medical Compliance is applied within all pharmacovigilance activities.
To work cross functionally within project teams to meet Company objectives and to represent the Department of Pharmacovigilance in a team-oriented manner and delivering quality and timely input to meet the needs of the project team.
Any other activity that may reasonably be required.

Requirements:

Education
Medically qualified physician with postregistration clinical experience. Completed specialist training and/or clinical exposure in immunology and/or haematooncology 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 regulatory requirements global pharmacovigilance regulatory requirements including both 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

The anticipated salary for this position will be$250000 to $275000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience skill set qualifications education (including applicable licenses and certifications job-based knowledge location and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs Sick Days and Volunteer Days
• Healthcare Benefits (Medical Dental Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America Inc. to provide equal employment opportunity to all qualified persons without regard to race religion creed color pregnancy sex age national origin disability genetic trait or predisposition veteran status marital status sexual orientation or affection preference or citizenship status or any other category protected by law.

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Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR if you are located in the European Union you have the right to request access to your personal data to request that your personal data be rectified or erased and to request that processing of your personal data be restricted. You also have the right to data portability and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data you may contact us by email at .

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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