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Medical Safety Specialist
2 weeks ago
Job Summary
We are seeking a Medical Safety Specialist to oversee the drug surveillance program, including follow-up, risk assessment, and relatedness to product on adverse reaction reports. The selected candidate will also be responsible for ensuring safety in clinical trials and post-marketing programs.
Main Responsibilities:
- Monitor the clinical safety of projects/products, including literature review, evaluation of individual cases or signal detection, and responding to safety-related questions.
- Perform medical assessments and related activities for cases, including collecting additional follow-up information as necessary, medical evaluation of product quality defects with adverse events, and review of line listings of single cases.
- Identify safety signals based on the review of solicited or unsolicited single cases.
- Perform signal detection, monitoring, and evaluation of all safety signals.
- Provide inputs into responses to inquiries from regulatory authorities or healthcare professionals on safety issues.
- Prepare safety data for Health Authority review boards.
- Collaborate effectively on clinical safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology, and other related departments.
Key Performance Indicators:
- Timeliness and quality of safety analyses, interpretations, and presentations.
- Compliance with internal and external regulations and procedures.
- Consistency and quality of safety deliverables.
