NJ Employer Submissions Specialist Global PV Operations in Princeton, New Jersey

OtsukaOverview: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 managementResponsibilities:Required:Knowledge 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 preferredSkills 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 regulationsEducation 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 dat