The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Materials, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment. Asahi Kasei Therapeutics is the global specialty pharmaceutical business of Asahi Kasei. We are a commercial-stage company committed to positively impacting health by expanding therapeutic options that improve the lives of patients around the world. Drawing upon our strong heritage of scientific innovation, we aim to help reshape care in transplantation, nephrology, immunology, infectious diseases and other underserved conditions. Job Description: Position Overview This position of Director Global Drug Safety and Pharmacovigilance (GDSPV) contributes to the Company’s success in leading and providing direction for all product safety and pharmacovigilance activities in compliance with global pharmacovigilance and regulatory requirements. The incumbent serves as a safety liaison with the Company’s cross-functional teams and is responsible for oversight, strategic planning, and execution of pharmacovigilance, drug safety, case management and inspection readiness for investigational and marketed products, while striving for operational excellence and ensuring Company license partner and vendor contractual obligations are maintained. Summary of Key Responsibilities · Contribute to the development of GDSPV Operation strategy, goals, and objectives and assist with the implementation and training to support department goals and initiatives. · Manage all Company pre- and post-marketing safety surveillance activities for its products throughout the life cycle in compliance with International Council for Harmonization (ICH) guidelines, FDA/EMA applicable global health authority regulations related to Good Pharmacovigilance Practices (GVP), and Company procedures. · Provide pharmacovigilance and drug safety leadership and input for the Company’s clinical development and postmarketing programs, including Clinical, Investigator Sponsored, Compassionate Use, Named Patient Use, and Disease Monitoring Programs while collaborating with Clinical Operations, Medical Affairs, Data Management, Biostatistics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs), and other internal and external entitles to contribute to overall program execution while ensuring safety strategy, quality compliance and operational excellence. · Contribute to the preparation and review of safety-related section(s) for clinical, regulatory, and scientific documents, including protocols, informed consent/assent forms, Case Report Forms (CRFs), Statistical Analysis Plans, Clinical Study Reports/synopses, Integrated Summaries of Safety (ISS), New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory agency responses, Institutional Review Board (IRB)/Ethics Committee (EC) requests, briefing books, manuscripts/journal article, and other documents. · Direct the creation and maintenance of the Company’s Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI), including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels, and other associated product labeling. · Oversee the preparation of pre- and post-marketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and Six-Month Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports, ensuring safety profile/topics across various regulatory safety documents for the Company’s assigned products. · Oversee risk-benefit evaluations, the preparation and review of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization, and effectiveness measures in accordance with regulatory requirements. · Develop and manage pharmacovigilance activities and safety data exchange agreements with company’s license partners. · Responsible for overall vendor performance and vendor service outputs (delivered timely and within budget) including but not limited to: o Governance of US adverse event (AE)/product complaint (PC) call center; o Governance of individual case safety report (ICSR) processing by outsourced CRO vendor, including the review and monitoring of compliance through various monitoring reports/key performance indicators (KPIs); o Review and approval of safety-related section of aggregate reports (DSUR, PSUR, PADER, RMPs); o Collaboration with vendors to develop process-related documents for the purposes of improvement and standardization of new processes; o Implement and maintain knowledge of safety database systems, ensuring all Company ICSRs are included within a global safety database. · Develop and maintain pharmacovigilance quality system. · Contribute to development and maintain the Pharmacovigilance System Master File (PSMF) to support European filings and regulations as applicable. · Create and maintain standard operating procedures and working practices to ensure inspection. readiness and compliance with regulations and guidelines. · Serve as the company’s pharmacovigilance subject matter expert when participating in internal/external audits and regulatory inspections. · Manage pharmacovigilance budget and forecasting activities. · Support signal detection activities to ensure signal identification, evaluation, and validation, and communication of safety assessments (written and verbal) of safety risks in collaboration with essential team members. · Support preparation and participate in Safety Management Team (SMT), Benefit Risk Assessment Team (BRAT), and other forum meetings to ensure oversight of all company products. · Represent the company in product safety meetings with its license partners and CROs · Provide training to company personnel regarding pharmacovigilance requirements and compliance and manage training compliance. · Maintain current knowledge of global regulations and regulatory guidelines. · May perform other drug safety and pharmacovigilance activities appropriate to experience and expertise. Required Qualifications and Skills · Bachelor’s degree in scientific / technical discipline, RN, or equivalent healthcare experience · At least 7 years’ drug safety experience in the pharmaceutical industry · Strong knowledge of US and EU pharmacovigilance regulatory requirements and current pharmacovigilance practices · Solid experience with drug safety databases, especially with Argus · Solid vendor management/governance experience · Self-motivated, detail-oriented, with the ability to prioritize and plan effectively · Excellent leadership qualities and written and verbal communication skills · Ability to work in a dynamic, fast-paced environment with shifting priorities · Experience with internal audits and global regulatory inspections · Strong organizational and project management skills · Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro · Travel Requirements: <10% #LI-SI1 As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment. Be cautious of fraudulent communications claiming to be from Asahi Kasei. Incidents have occurred in which individuals impersonating Asahi Kasei recruiters have contacted people on LinkedIn requesting personal information. If someone does not have a verification badge, that person is not authorized to engage in recruitment activities on behalf of Asahi Kasei. Please also note that we never ask applicants to make any payments in the recruitment process. If you receive any suspicious messages or recruitment outreach that does not meet these criteria, please do not respond, and report the matter directly to LinkedIn. Asahi Kasei in North America emphasizes recruiting key talent within the region. Across our multiple business units, we focus on growth, innovation, and initiative to help develop our people and give them the resources they need to succeed. Part of our mission is to be a good corporate citizen, dedicating our time to employees, customers, and communities around us. As an employer, Asahi Kasei offers a comprehensive benefits package, growth opportunities throughout our companies, and a diverse environment to enhance your career. About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 46,000 employees around the world, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. In North America, Asahi Kasei currently has over 23 business units and 10,000 employees. Our People Asahi Kasei recognizes that our people are our greatest strength. We operate with an emphasis on developing our employees and promoting from within. Our broad spectrum of companies within the Material, Homes, and Health Care sectors allows employees to collaborate across locations and industries. The possibilities for employees will continue to grow as we accelerate new business activity internally and externally through mergers and acquisitions. For assistance in submitting your application or with the careers site, please reach out to [email protected]. Please note we do not accept resumes or applications via email. Don't see an opening that matches your skills? Setup job alerts by selecting Sign In, located in the upper right of the page, to create an account.

Director, Global Drug Safety & Pharmacovigilance Operations.

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