Safety & PV Submission Spec I
New
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JobgetherPharmacovigilance, clinical research
Workplace type: Remote; based in Brazil.Full-Time
Salary not disclosed
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Job Details
- Required Skills
- Microsoft ExcelPowerPoint
Requirements
- Hold a bachelor's degree in Life Sciences or a related discipline, or be a registered nurse or pharmacist; equivalent combinations of education and professional experience may be considered.
- Previous experience in safety reporting, pharmacovigilance, clinical research, or a related regulatory environment is preferred.
- Familiarity with safety database systems and pharmacovigilance processes is an advantage.
- Have working knowledge of medical terminology relevant to clinical safety reporting.
- Understand ICH guidelines and regulatory requirements relating to pharmacovigilance and safety reporting.
- Be familiar with GCP, GVP, SOPs, Work Instructions, and clinical development processes.
- Be proficient in Microsoft Word, Excel, and PowerPoint.
- Be familiar with Microsoft Visio, Outlook, internet-based tools, and shared document management or collaboration platforms such as TeamShare or equivalent.
- Demonstrate strong organizational and documentation management skills, attention to detail, and accuracy.
- Manage multiple tasks and competing deadlines while maintaining consistent performance.
- Work independently and contribute effectively to a collaborative, cross-functional team.
- Communicate professionally with internal and external stakeholders, in writing and verbally.
- Apply analytical thinking and decision-making when handling documentation discrepancies or competing priorities.
- Maintain confidentiality, data privacy, and regulatory compliance.
Responsibilities
- Prepare, compile, and assemble expedited and periodic safety reports for clinical trials and post-marketing safety programs.
- Coordinate submissions to regulatory authorities, ethics committees, and clinical investigators within applicable deadlines.
- Track submission statuses, timelines, and outstanding documentation.
- Review safety reporting documents for completeness, consistency, and project-specific compliance.
- Apply relevant regulatory intelligence and safety reporting guidelines when coordinating submissions.
- Organize, maintain, and file safety-related documentation in electronic or physical formats.
- Distribute completed safety submission documents to clients and other stakeholders.
- Collaborate with project teams, external partners, clients, and other stakeholders on safety reporting activities.
- Follow applicable SOPs, Work Instructions, GCP, GVP, ICH guidelines, and data privacy requirements.
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