Responsible for ensuring the satisfaction of Global Pharmacovigilance (GPV) organization needs for safety systems. Provide technical and managerial leadership to a global team of technical staff ensuring close interaction with the end-user community with the objective of delivering high quality, compliant, validated and timely solutions.
Job duties include:
Responsible for maintaining data and system configurations for safety systems in accordance with Otsuka methodologies, applying knowledge of technology, regulations, policies, processes and/or procedures to control and maintain accurate records.
• Responsible for maintaining the validated state of systems by overseeing validation tasks across the GSDM team and in close interaction with Otsuka Global Quality Systems teams.
• Work closely with all GPV functional areas to develop solutions, work plans and oversee their implementation, including but not limited to gathering, business requests for safety systems, changes and upgrades. Provide subject matter expertise for safety system upgrades and changes.
• Manage system incidents, changes and problems by application of Otsuka and industry best practices.
• Provide accurate timely reports on the status of incidents, changes, problems and assigned projects.
• Responsible for managing offshore support team and coordinating their daily activities.
• Responsible for producing weekly performance metrics quantifying the support work.
• Assist in defining, designing, developing, testing and deploying systems.
• Ensure timely and appropriate escalation of risk, issues and concerns to the GSDM leadership.
• Responsible for conducting E2B pilots with Regulatory Agencies and partners.
• Support GPV Business intelligence in the development, validation and management of necessary line-listings, aggregate summaries, data exports or customized reports from safety data sources.
• Provide/support user training on safety systems.
• Perform other tasks as assigned.
• Bachelor’s degree in Computer Science, Information Systems or related field.
• Seven (7) years of experience leading in an IT/Informatics team setting.
• At least five (5) years of experience supporting Pharmacovigilance/Drug Safety with subject matter expertise in software-based drug safety systems such as Argus Safety Suite or Aris.
• At least five (5) years of experience in and detailed knowledge of ICH E2B requirements, Argus E2B and gateway configuration.
• Ability to understand and gather the essential user requirement and translate it into technical solution.
• Ability to communicate complex technical subjects clearly and succinctly in writing, visual and verbal forms to non-technical audiences in English. Ability to communicate in Japanese is strongly desired.
• Demonstrated resourcefulness and unconventional thinking applied to solving real-world problems related to safety systems.
• Demonstrated experience with data migration of safety data for global systems, especially Japan.
• Knowledge of MedDRA/MedDRAJ, WHO-DD, J-Drug Dictionary coding dictionaries.
• Strong knowledge of relevant FDA, EU, MHLW, Health Canada and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing pharmacovigilance.
• Knowledge of pharmaceutical/biotech industry and the overall drug development process.
• Demonstrated skill and knowledge of PL/SQL, SQL, SQL Developer, Oracle database administration, Argus Safety Suite, Empirica Suite, TOAD, ITIL, virtualization, network and system security concepts.
• Experience in tools like JReport and Spotfire. Experience with OBIEE, Cognos, LSH is desirable. .
• Computer skills including proficiency in the use of Microsoft Word, Excel, Access and PowerPoint, including VBA
• This position requires travel within the U.S. and internationally (approximately 15%).
Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.
Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.