- Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures
- Ensure compliance of operations with governing regulatory requirements
- Create, maintain and assume accountability for a culture of high customer service
- Undertake primary medical review of cases, including medical assessment of the case for seriousness, listedness/labeling, causality, adverse event coding and narrative review.
- Update and document daily case data, case-feedback in appropriate trackers/tools to facilitate tracking and workflow management
- Assume complete responsibility for all assigned deliverables in line with expected quality, compliance and productivity SLAs and KPIs.
- Undertake and complete additional tasks/activities, assigned by supervisor, as required
- Provide training
- Bachelor’s degree in Medical Science or equivalent degree (Nursing)
- 2-3 years of clinical practice experience
- Up to 2 years of pharmaceutical industry experience, including pharmacovigilance (case processing, medical review) and / clinical research preferred
Special Skills & Knowledge
- Clinical Research
- Good understanding of regulatory requirements and ICH-GCP guidelines
- Technical proficiency with Microsoft Office suite of applications
- Strong working knowledge of medical sciences, diagnosis and therapeutics including drug treatments and procedures
- Good verbal and written communication skills
- Focus on quality and attention to detail
- Ability to review, analyze & synthesize medical information
- Good understanding of customer needs and expectations
- Highly focused on quality and timelines for medical deliverables
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