Global Country Safety Specialist

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

 What You'll Be Doing:

• Reviews, supports, and maintains the safety regulatory intelligence for assigned countries and globally by reviewing local requirements on a periodic basis and cross referencing with Premier’s Regulatory Intelligence platform.

• Submits safety reports to regulatory authorities and ethics committees globally via registered portals or local regulatory systems eg. udravigilance/FAERs etc.

• Submits safety reports globally to sites as required in the protocol and the SMP.

• Maintains tracking of global safety submissions either using a manual tracker or a safety document distribution platform.

• Performs QC of Global submission evidence against the tracker for manual submissions and in the safety portal for offline submissions at a level determined in the SMP.

• Prepares expedited and periodic safety report submission status updates and KPIs, as required, for Sponsor/Customer

• Acts as a local SME and reviews the safety intelligence globally.

• Files documents according to project specific requirements (electronically or in hard copy as applicable) and submission evidence in the eTMF.

• Supports in the preparation of data for internal project review meetings and participates as required.

• Participates in audits and inspections as required/appropriate.

• Maintains a detailed understanding and stringent compliance with Standard Operating

• Procedures (SOPs), Working Guidance documents, global drug/biologic/device regulations, GCP/GVP guidance.

 What We Are Searching For:

• 3-5 years of experience in Safety submissions related activities or relevant regulatory field.

• Good understanding in Clinical Trial PV Submissions for allocated region and also at a more global level.

• Good experience in registering for submission accounts in different countries, completing submissions manually or through any System.

• Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and global 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.