Associate Director, Safety Data Management
: Job Details :

Position Summary Oversees the Change Management Process of GSDM and GPV Help desk to monitor reported incident and change requests. Maintain and manage safety systems used by GPV. Key Job Responsibilities 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 Testing and Validation 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. Responsible for managing offshore support team and coordinate their daily activities. Responsible for producing weekly performance metrics quantifying the support work. Assist in defining, designing, developing, testing and deploying systems. Manage system incidents, changes and problems by application of Otsuka and industry best practices. Ensure timely and appropriate escalation of risk, issues and concerns to the GSDM leadership. Provide accurate timely reports on the status of incidents, changes, problems and assigned projects. Demonstrated experience in 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. Knowledge, Skills, Competencies, Education, and Experience Required: Knowledge Minimum 5 years of Pharmacovigilance / Drug Safety experience or equivalent required with subject matter expertise in software-based drug safety systems, direct experience with Argus highly desired Both pre-approval and post-marketing experience in a global environment highly desired. Strong knowledge of pharmaceutical/biotech industry and the overall drug development process Knowledge of relevant FDA, EU, MHLW, Health Canada and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments Understanding and familiarity of the drug development process Knowledge of MedDRA and WHO-DD coding dictionary Skills In depth knowledge of PL/SQL, Oracle 9i/10g/11g, SQL Server, Argus suite, TOAD, Sql Developer Experience in tools; JReport ver 12, 13.1 Computer skills including proficiency in the use of Microsoft Word, Excel, Access and PowerPoint. Excellent oral and written English communication skills Education and Related Experience BS degree in a life sciences field with minimum of 4 years of experience in the pharmaceutical industry. Physical Demands and Work Environment Travel (approximately 10%) 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. Equal Opportunity Employer 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. Competencies Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business. Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders. Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. Empowered Development - Play an active role in professional development as a business imperative. Come discover more about Otsuka and our benefit offerings; . 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 be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic . If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability . You can request reasonable accommodations by contacting Accommodation Request . Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: 800-###-####. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., a nd Otsuka Precision Health, Inc. (Otsuka ) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.