Reporting to Otsukas Global Head of Pharmacovigilance, the Director, Safety Data Management, will serve as the Global Head Safety Data Management. Her/his responsibility will be to manage all aspects of Otsuka's Global Pharmacovigilance (GPV) database, information management, and technology needs associated with safety information, collection, tracking, retrieval, and reporting in close interaction with the end-user community with the objective of delivering high quality, compliant, validated, and timely solutions
Drive strategy for the development of global safety data management group within GPV.
Develop and drive technology strategies to meet existing and projected GPV needs to ensure satisfaction of evolving business and PV regulatory
Evaluate current safety systems, software, and technology in collaboration with relevant stakeholders to determine unmet needs and proactively provide proposals for enhancing and streamlining database
Oversee development and implementation of signal detection tools for investigational compounds and marketed products.
Manage the full systems lifecycle from implementation to support to retirement in accordance with Otsuka and industry standard methodology, to ensure compliance at all times. This includes development of scope, gathering of business requirements and functional specifications, and implementation, testing, and
Conduct routine and ad hoc data extractions and assist in responding to regulatory authority
Manage registration, testing, and maintenance of all electronic submission processes with external parties and lead efforts on initial development and modifications to departmental data entry manuals
Demonstrated record of having successfully implemented and managed PV systems from concept to go-live and continuing through operational
Have a demonstrable knowledge of combining GPV data from multiple databases, especially Japan, the EU, and the US to create a single global safety
Possesses leadership and managerial expertise to successfully integrate acquisitions and to work with external partners to ensure compliance of our
Have experience in with a globally distributed business and IT teams, especially in Japan and India.
Possess 5 years of experience performing coding dictionary maintenance in MedDRA, MedDRA J and WHODD.
Possess 5 years of experience in pharmacovigilance (PV) for software-based drug safety
Possess 10 years of experience applying FDA, EU, PMDA, Health Canada, and ICH guidelines, initiatives, and regulations governing both clinical trial and post-marketing safety environments to database and IT
Possess 10 years of experience implementing signal detection, risk management, and other PV programs and in managing specialty and IT
Possess 10 years of experience leading and managing teams, in a culturally diverse and globally dispersed Must also have demonstrable previous experience and success in establishing, recruiting and sustaining a PV Informatics/IT function within a pharmaceutical setting
Possess 10 years of informatics experience directly supporting PV globally, especially with Japanese, US, and European PV
Have experience with Regulatory Authority Inspections (PV and GCP)
Candidate should be able to demonstrate eminence and thought leadership within the industry in the area of PV
Knowledge & Skills
Detailed knowledge of Argus and Argus J At least 5 years of experience and detailed knowledge of ICH E2B requirements, Argus E2B, and gateway configuration.
Demonstrated experience in conducting E2B pilots with Regulatory Agencies and companies with which we collaborate
Demonstrated experience with migration for safety data for global systems, especially Japan
Knowledge of MedDRA and WHO-DD coding dictionary
Knowledge of relevant FDA, EU, PMDA, Health Canada and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety
Knowledge of PMDA green book
Strong written and verbal communication skills, including good command of
Strong written and verbal communication in Japanese is highly
Both pre-approval and post-marketing experience in a GPV function is highly desired
Strong knowledge of pharmaceutical/biotech industry and the overall drug development process
Computer skills including proficiency in use of Microsoft Word, Excel, Access & PowerPoint
Education and Related Experience:
Requires a graduate or foreign equivalent degree in business, computer science, life sciences or a
related field plus 8+ years of relevant experience in drug safety/pharmacovigilance, or related fields in the pharmaceutical industry.
Requires a bachelor's or foreign equivalent degree in business, computer science, life sciences or a
related field plus 12+ years of relevant experience in drug safety/pharmacovigilance, or related fields in the pharmaceutical industry
Physical Demands and Work Environment
Occasional teleconferencing at "off business" hours resulting from meetings being held in US and Japan
Up to 20% international and domestic travel
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