Safety & PV Submission Spec I

Accountabilities:

Assist with the preparation, design, compilation, and assembly of expedited and periodic safety reports for clinical trials and post-marketing safety programs.
Support the submission of safety reports to regulatory authorities, ethics committees, and clinical investigators, ensuring compliance with applicable deadlines and submission requirements.
Maintain accurate tracking records for safety submissions, monitoring submission statuses, timelines, and outstanding documentation.
Review safety reporting documentation to help ensure completeness, consistency, and compliance with project-specific requirements.
Apply relevant regulatory intelligence and safety reporting guidelines when preparing and coordinating submissions.
Organize, maintain, and file safety-related documentation in electronic or physical formats, following established project procedures.
Distribute completed safety submission documents to clients and other relevant stakeholders as required.
Collaborate professionally with internal project teams, external partners, clients, and other stakeholders to support effective safety reporting activities.
Provide administrative and operational support for additional project-related tasks associated with pharmacovigilance and regulatory submissions.
Follow applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and International Council for Harmonisation (ICH) guidelines.
Maintain awareness of relevant global regulations governing drugs, biologics, and medical devices, ensuring that all activities meet applicable compliance standards.
Adhere to data privacy requirements, confidentiality standards, and internal quality procedures throughout the submission process.
Manage multiple assignments and deadlines while maintaining accuracy, organization, and consistent documentation quality.
Requirements:
Bachelor's degree in Life Sciences or a related discipline, or a qualification as a registered nurse or pharmacist. Equivalent combinations of education and professional experience may also 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.
Working knowledge of medical terminology, particularly terminology relevant to clinical safety reporting, is preferred.
Good understanding of ICH guidelines and regulatory requirements relating to pharmacovigilance and safety reporting.
Familiarity with Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), SOPs, Work Instructions, and clinical development processes.
Proficiency in Microsoft Office applications, particularly Word, Excel, and PowerPoint.
Familiarity with Microsoft Visio, Outlook, internet-based tools, and shared document management or collaboration platforms such as TeamShare or equivalent systems.
Strong organizational and documentation management skills, with excellent attention to detail and a high level of accuracy.
Ability to manage multiple tasks simultaneously, prioritize competing deadlines, and maintain consistent performance in a structured environment.
Ability to work independently while contributing effectively to a collaborative, cross-functional team.
Excellent written and verbal communication skills, with the ability to interact professionally with internal and external stakeholders.
Strong analytical thinking and decision-making abilities, particularly when handling documentation discrepancies or competing priorities.
Reliability, accountability, and a proactive approach to identifying and addressing potential issues.
Commitment to maintaining confidentiality, data privacy, and regulatory compliance in all professional activities.
Benefits:
Fully remote opportunity: Work from home in Brazil through a remote working arrangement.
International exposure: Collaborate with global clinical research and pharmacovigilance teams across different functions and therapeutic areas.
Professional development: Build specialized knowledge in drug safety reporting, pharmacovigilance, clinical trials, and regulatory submissions.
Career progression: Access opportunities to develop your expertise and explore different career paths within the clinical research and life sciences industry.
Training and development: Benefit from technical and therapeutic-area training, knowledge-sharing initiatives, and professional development support.
Supportive management: Work with engaged managers and experienced professionals in a collaborative environment.
Recognition and rewards: Access peer recognition initiatives and a total rewards program.
Collaborative culture: Join a diverse international team that values different perspectives, teamwork, and shared problem-solving.
Meaningful impact: Contribute to clinical research and drug safety processes that help advance therapies and improve patient outcomes.
Employment type: Full-time.
Work arrangement: Remote (pre-approved), based in Brazil.