Safety submissions specialist

Bengaluru - India

Monthly Salary: Not Disclosed

Posted on: 9 hours ago

Vacancies: 1 Vacancy

Job Summary

Position Summary:

The Safety Submission Specialist under minimal supervision will assume the responsibility of reviewing and transmission of required individual cases safety reports (ICSRs) for submission (paper and electronic) to global regulatory agencies business partners affiliates and other destinations. Must maintain continuous knowledge and expertise of local and global requirements for safety reporting.

Essential functions of the job include but are not limited to:

Monitor the Drug Safety Inbox for incoming submission acknowledgements and confirmations of expedited reports
Maintain various spreadsheets including but not limited to distribution/submission trackers
Generate final clinical trial regulatory reports (e.g. CIOMS I MedWatch 3500A XML) from the global safety database for distribution/submission
Prepare and distribute final submission documents including Investigator Safety Letter
Perform case closure and electronic filing of SAE related documentation
Complete expedited report deviations which includes initiation investigation extension requests and CAPAs as appropriate
Perform SAE reconciliation and send queries as appropriate
Reconcile and send SUSAR Gap Packs
Maintain and update expedited email distribution lists
Reconcile compliance metrics
Support generation of overall distribution/submission compliance metrics
Monitor regulatory intelligence databases for regulation updates and provides country specific reporting information to support the development of Safety Reporting Plans
Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate
Maintains understanding and compliance with SOPs Work Instructions (WIs) global drug/biologic/device regulations GCPs ICH guidelines GVP project/program plans and the drug development process
Attends Department meetings

Qualifications:

Minimum Required:

Must have sufficient experience and a demonstrated knowledge and understanding of global safety reporting regulations and guidelines including the FDA ICH & EU Regulations and Requirements for Pharmacovigilance
Knowledge of the ARGUS Safety Database
Minimum 2 years of experience in clinical trial drug safety in the Pharma/CRO industry
Experience with EMA EudraVigilance UK MHRA and other recognised reporting portals
BA/BS preferred

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Required Experience:

Position Summary:The Safety Submission Specialist under minimal supervision will assume the responsibility of reviewing and transmission of required individual cases safety reports (ICSRs) for submission (paper and electronic) to global regulatory agencies business partners affiliates and other dest...