safety nurse - drug safety / PharmacovigilanceCovance America

Job Overview:
Strategic
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
Operational
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
Education/Qualifications:
Qualifications
Bachelor's degree in Medical Science or equivalent degree (Nursing)
Special Skills & Knowledge
Clinical Research
Good understanding of regulatory requirements and ICH-GCP guidelines
Technical proficiency with Microsoft Office suite of applications
Key Competencies
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
Experience:
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