We are currently searching for a skilled professional to join a well-known client’s team as a Submission Specialist in Princeton, New Jersey. The Submission Specialist will assume the responsibility of paper and electronic submission of all post-marketing individual cases safety reports and clinical adverse event reports to Global Health Authorities and Client Partners. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Review ICSR’s prior to performing transmission of ICSR to Global Health Authorities and Client Partners
- Maintain continuous knowledge and expertise of local and global requirements for safety reporting
- Prepare global submissions
- Reviews regulatory issues with supervisorand assists in the negotiation of submission issues with agency personnel
- Prepare local paper submissions to FDA in accordance with Client processes
- Complete all on time submissions to all applicable reporting destinations
- Generate CIOMS I form, 3500 FDA MedWatch Form or similar to global partners based on defined timelines
- Monitors the safety database for failed submissions
- Prepares safety information for submission to local PV representatives
- Follow-up with Local Safety Managers 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 review and maintenance of reporting rules within the Argus Safety Database
- Minimum of 2 years drug safety experience required
- Demonstrated proficiency in safety database functionality
- Global Drug Safety Case processing experience
- Prior submission experience is required, medical device
- Must have sufficient experience and a demonstrated knowledge and understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance
- Knowledge of the ARGUS Safety Database, case processing
- Knowledge of the Global Pharmacovigilance organization is desired
- Knowledge of FDA eSubmitter tool is highly desired
- Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
- Proficiency in use of documented system such as GEPIC
- Bachelors of Science or related healthcare degree (may be waived for relevant experience)
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.