Pharmacovigilance Data Analyst

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 areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes three offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.

As a patient centric organization that strives to deliver innovative medicines to meet unmet needs, we feel that it is critical to follow the safety guidelines defined by CDC and OSHA. We believe the COVID-19 vaccine is the best way to manage COVID risk to you, your colleagues, your family and our society. With that in mind, we are taking the essential step to ensure the safety of our employees during this health crisis by requiring all US employees, temporary workers, agency employees and independent contractors to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. In accordance with applicable law, individuals may seek an accommodation for medical or disability-related conditions or sincerely held religious beliefs.

Summary:

This position is responsible for trend analysis, piloting different methodologies to detect new trends to aid signal prediction and monitor the safety profile of products developed and marketed by the company. 

Essential Functions:

•    Conduct regular trend analysis of Pharmacovigilance data
•    Implement and pilot various methodologies to detect new trends in Pharmacovigilance data.
•    Interpret, analyze and present complex data to identify potential safety issues related to the company's products.
•    Identify opportunities to improve benefit profile and maximize value of the products. 
•    Conduct retrospective and prospective analysis of data for signal detection.
•    Work closely with the Pharmacovigilance team to ensure appropriate evaluation and management of safety data.
•    Provide guidance and support to team members on data analysis and statistical methodologies.
•    Collaborate with cross-functional teams to ensure timely and effective communication of safety findings.
•    Participate in the development and implementation of Pharmacovigilance processes and procedures.
•    Maintain a strong knowledge of Pharmacovigilance regulations and guidelines.
•    Prepare and present reports to management on Pharmacovigilance data trends and findings.

Requirements:

Education
•    Bachelor’s degree in Pharmacy, Life Sciences, Mathematics or a relevant degree in a health science field.  Master’s degree a plus.

Experience
•    Minimum three (3) years in Pharmacovigilance, data analysis or a related field.
•    Demonstrated experience with data analysis and interpretation as an understanding of safety and Pharmacovigilance principles required.
•    Therapeutic experience in the areas of Oncology, Nephrology, Immunogy & Allergy is a plus. 

Technical Skills
•    Strong knowledge of Pharmacovigilance, safety databases, data analysis and statistical methods
•    Demonstrated ability to evaluate, interpret and present complex scientific data (preclinical, clinical, translational) to inform scientific hypotheses and development strategy. Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
•    Proficiency in R or other programming languages is required
•    Proficient in MS Office Suite.(Outlook, Word, Excel and PowerPoint)

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.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 135 Route 202/206, Suite 6, Bedminster, NJ 07921 USA and can be contacted by emailing [email protected]. Controller’s data protection officer can be contacted at [email protected]. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

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 [email protected].

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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