Description
Position at Premier Research
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases. We’re looking for an exceptional Safety Submission Specialist to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered. Join us.
Summary
The Safety Submission Specialist is a critical role in the PV system; responsible for accurate, timely and appropriate E2B and manual submissions of individual case safety reports (ICSRs) and aggregate reports to Regulatory Authorities, Ethics committees and other stakeholders according to regulatory requirements. The role also involved set up of the submission process for each study and requires continual review of safety regulatory intelligence and generation of performance related KPIs.
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
Apply through below link