The Submission Specialist, under minimal supervision, will assume the responsibility of reviewing and transmission of required individual cases safety reports (ICSRs) for submission (paper and electronic) to global regulatory agencies, business partners, affiliates and other destinations. Submission specialist will perform the reconciliation of submission dates and assist with site audit requests. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting.
As a member of the Drug Safety and Pharmacovigilance department, the Global PV Workflow Sr. Associate is responsible for participating in the collection, safety review, processing and reporting of adverse event data in compliance with applicable FDA and global regulations. The Global PV Workflow Sr. Associate will ensure the uniform and timely processing and reporting of adverse events to regulatory authorities and business partners in collaboration with Drug Safety Operations team members. Global PV Workflow Sr. Associate will participate in the set-up and development of monitoring tools and maintenance of adverse event workflows within Avisso to meet global regulatory reporting requirements. In addition, the Global PV Workflow Sr. Associate will assist with the case readiness for internal and external reports (PSURs, PADERs, etc.). The Global PV Workflow Sr. Associate, will coordinate and monitor the department’s workflow, and assist in special projects as assigned. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting.
Education and Related Experience
*Safety experience is defined as actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
**Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Monitor, Regulatory Affairs, or Quality Assurance
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.
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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.