We seek a Safety Data Coordinator who will provide administrative support to the Safety and Pharmacovigilance department staff while adhering to all data protection guidelines, Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practices (GCPs), regulatory guidelines, and study procedures.

Main functions:

- Recording all adverse events or endpoint source documentation and tracking them by Sponsor specifications; distributes incoming mail and faxes.
- Redacting patient information or images by data protection guidelines and ICH GCPs.
- Performing file creation, tracking, retention and the maintenance of paper and electronic as well as the maintenance of industry reference documentation.
- Entering data into the safety database or adjudication database by sponsor specific guidelines and Company standards.
- Ensuring the following of current conventions when entering cases into the Safety database as well as assisting in the writing of non-serious narrative for post-marketing projects as may be applicable.
- Assisting in the distribution of expedited safety reports and periodic reports to sites, Ethics Committees (ECs), Institutional Review Boards (IRBs), and Regulatory/Competent Authorities (RAs/CAs), according to project-specific plans.
- Assisting with the maintenance of the SharePoint website for Safety and Pharmacovigilance;
- Escalating issues to management as at when needed as well as maintaining the understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, and the drug development process.
- Acquiring basic understanding and maintains knowledge of ongoing projects and disease-related terminology.
- Performing other work related duties as at when assigned.

Requirements:

- Newly graduated with nominal clinical research or administrative work experience or equivalent combination of education and experience.
- Database and medical terminology are preferred coupled with proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail skills.
- Excellent oral and written communication skills coupled with strong interpersonal and customer service skills appropriate to a professional medical setting.
- Excellent strong organizational and documentation skills coupled with detail orientation and a high degree of accuracy.
- Ability to handle multiple tasks and meet deadlines in a dynamic environment.