Drug Safety Submissions Specialist

Individuals hired for this full-time position need to be available to work on site at our client’s office, located in Princeton, New Jersey, for two or three days a week potentially beginning January 2022 (due to the pandemic onsite work status will be reassessed on an ongoing basis). We are looking to interview, hire and onboard prior to January.

Ideal candidates for this Drug Safety Submissions Specialist position will have a minimum of two years Drug Safety experience that includes experience with regulatory submissions and a Bachelor of Science or related healthcare degree and:

• Can effectively understand and integrate scientific data from a variety of sources
• Knows how and when to apply organizational policies or regulatory procedures
• Have excellent verbal and written communication skills
• Can successfully work independently and collaboratively, multi-task, prioritize,and meet tight deadlines
• Are highly proficient with Microsoft Word, Excel, PowerPoint, and Outlook

Responsibilities include but are not limited to:

• Play an integral role in management of daily operational activities of the Global Submissions Team within Case processing
• Responsible for managing timely submission of Global ICSRs to various Health Authorities, License Partners and CROs
• Monitoring of Global submissions mailbox to address all the high priority emails/ queries received from health authorities/ license partners related to ICSR submissions
• Prepare local paper submissions to US FDA in accordance with client processes
• Responsible to address daily worklist to complete submissions to all applicable reporting destinations
• Generate, Review, and Transmit reports to all Global Health Authorities including but not limited to FDA European Agencies, Health Canada, and various other Health Authorities
• Timely submission of appropriate reports to global partners based on defined timelines as per the PVA
• Responsible for timely submission of expedited ICSR reports to Ethics Committees and Investigators based on the country requirements
• Monitoring the safety database for failed transmissions to resolve the issue in a timely manner
• Involved in preparing safety ICSR submission package to Health Authorities as per the requirements
• Follow-up with Case Processing team and Medical Reviewers to request appropriate case correction for timely submissions of reports
• Identifying root cause for late ICSR submissions and to provide appropriate corrective and preventive actions to Compliance and Business Management team
• Provide training and support to newer members of the submission team
• Collaborate with Regulatory Intelligence team, Safety Data Management to maintain accurate reporting rules in the Safety Database
• Review of Pharmacovigilance Agreements and Safety Management Plans to identify new requirements and/or updates for configuration of reporting rules in safety database

If you have skills and experience that you feel are a good fit for the position, please forward your C.V. to us.recruiting@apcerls.com . We look forward to receiving your resume.

EEO Disclaimer: APCER Life Sciences, Inc. is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, affectional or sexual orientation, age, gender identity or gender expression, national origin, nationality, disability, pregnancy status, breastfeeding practices, marital status, civil union status, domestic partnership status, veteran status, or any other classification protected by applicable federal, state, or local law.  APCER also complies with all applicable national, state and local laws governing non-discrimination in employment, as well as employment eligibility verification requirements and other requirements of each of its countries of operations with respect to immigration laws.