Safety Reporting Specialist
New
J
JobgetherPharmacovigilance, clinical research
Based in IndiaFull-TimeEntry
Salary not disclosed
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Job Details
- Experience
- Approximately 0–2 years of relevant experience
- Required Skills
- Project CoordinationMicrosoft Office
Requirements
- Bachelor's degree or equivalent qualification, supported by relevant academic or vocational training.
- Approximately 0–2 years of relevant experience in safety reporting, pharmacovigilance, clinical research, regulatory affairs, or a related field.
- Basic understanding of medical terminology and ability to work accurately with clinical and safety-related information.
- Basic familiarity with procedural documentation and global safety reporting requirements, including relevant US FDA regulations and guidelines.
- Understanding of safety report preparation, submission tracking, regulatory documentation, and reporting timelines is beneficial.
- Proficiency in Microsoft Office applications, particularly documentation, spreadsheet, and reporting tools.
- Basic understanding of safety database functionality.
- Strong time management, prioritisation, coordination, and attention to detail.
- Ability to handle sensitive clinical, medical, and regulatory information responsibly.
- Ability to work effectively in a fully remote position while meeting reporting deadlines.
Responsibilities
- Receive, prepare, and submit expedited and periodic safety reports to regulatory authorities, clients, and other relevant parties.
- Monitor safety report submissions, maintain accurate records, retain proof of submission, and escalate delays or quality concerns.
- Support compliance with global safety reporting requirements, regulatory guidelines, internal work practices, and client-specific SOPs.
- Prepare, organise, maintain, and archive regulatory submission files in accordance with established procedures.
- Coordinate safety reporting activities with project leads and support project milestones.
- Liaise with internal teams and stakeholders to coordinate reporting tasks and exchange required information.
- Generate reports and maintain reporting systems and repositories with accurate project information.
- Assist managers in collecting, consolidating, and validating project metrics.
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