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.
• Perform submission activities for all global health authorities
• Prepare local paper submissions to FDA in accordance with Otsuka processes
• Complete on time submissions to all applicable reporting destinations
• Review and transmit all approved reports to global regulatory agencies including but not limited to FDA, EMA, Health Canada, business partners, affiliates and any other applicable destinations
• Tracks and monitors all ICSR timelines to ensure that submissions to regulatory agencies, business partners, and contract research organizations (CROs) are compliant with the regulatory requirements
• Ensures the accuracy and completeness of electronic and hard copy regulatory submissions
• Follow-up with affiliates and other relevant parties to ensure on-time submissions and request details on late submissions
• Collaborates with Safety Data Management, Compliance and Business Management and local PV representatives to maintain accurate reporting rules
• Responsible for ensuring the accuracy of reporting rules within the Argus Safety Database
• Performs oversight and correspondence activities of the Submissions Mailbox
• Performs medical device submission
• Monitors the safety database to ensure successful and/or failed transmission
• Investigates reasons for failed transmissions and works with appropriate parties to make the corrections
• Mentor, train and support new members of the submission team
• Assist with site audit request, testing of reporting rules and other ad-hoc projects
• Performs case correction activities identified at submissions workflow when needed per Otsuka processes
• Review and confirm the readiness of a case for deletion
• Perform other activities as directed by Global Pharmacovigilance management
• Must have sufficient experience and a demonstrated knowledge and understanding of global safety reporting regulations
• Knowledge of the ARGUS Safety Database
• Knowledge and prior experience in case processing*
• Knowledge of the interworking’s of a Global Pharmacovigilance organization is desired
• Knowledge of the Medical Device Submission is preferred
• Excellent technical skills, including the ability to comprehend and integrate scientific data from a variety of sources
• Strong communication and writing skills
• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook), SharePoint and other electronic document repository systems
• Knows how/when to apply organizational policy or regulatory procedures to a variety of situations
• Ability to work under pressure in order to meet tight timelines
• Able to work effectively in a matrix environment
• Strong attention to detail along with the ability to problem solve
• Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations
Education and Related Experience
• Degree preferred to be in Bachelors of Science or related healthcare degree however may be waived for relevant experience**
• Minimum of 2 years drug safety experience required
• Demonstrated proficiency in safety database functionality including case processing
• Prior ICSR Submission experience is required
*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.