Safety submissions specialist
Precision for Medicine
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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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
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