About the job
Description
Position at Premier Research
Role Responsibilities
- Collaborates with the Sponsor and internal project team on setting up the safety reporting for the clinical trial
- Prepares and or reviews the Safety Reporting section of the Safety Management Plan
- Reviews, supports and maintains the safety regulatory intelligence for assigned countries or studies within the safety reporting platform.
- Applies safety reporting regulatory intelligence to all safety reporting activities
- Submits safety reports to regulatory authorities and ethics committees via registered portals or local regulatory systems eg. Eudravigilance/FAERs etc.
- Maintains tracking of safety submissions either using a manual tracker or a safety document distribution platform
- Supports the preparation of expedited and periodic safety report submission status updates and KPIs, as required, for Sponsor/Customer
- Employees may be regionally based, if there is a local requirement and in this capacity will act as a local SME and will review the safety intelligence for their region
- Files documents according to project specific requirements (electronically or in hard copy as applicable).
- Forwards completed safety submission documents to clients and other relevant parties
- Supports in the preparation of data for internal project review meetings and participates as required
- Participates in audits and inspections as required/appropriate
- Ensures all relevant documents are submitted to the Trial Master File (TMF) as per client/Premier SOPs for clinical trials and the appropriate system for post-marketing programs
- Maintains a detailed understanding and stringent compliance with Standard Operating Procedures (SOPs), Working Guidance documents, global drug/biologic/device regulations, GCP/GVP guidance.
Requirements
- Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
- 3-5 years of experience in Pharmacovigilance Case Processing related activities
- Working experience in Clinical Trial PV Submissions for all regions
- Working experience in registering for submission accounts in different countries, competing submissions manually or through any System
- Detailed knowledge and training of Eudravigilance
- Safety Database systems and knowledge of medical terminology required
- Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Clinical Safety and Pharmacovigilance
- Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), (or other management/shared content/workspace) and internet.
- Ability to work independently and in a team environment
- Good communication and interpersonal skills, both written and spoken
- Good organizational skills with proven ability to prioritize and work on multiple tasks and projects
- Detail oriented with a high degree of accuracy and ability to meet deadlines
How to Apply
Apply through below link