Patient Safety Associate Director

hace 7 días

Ciudad de México Gilead Sciences A tiempo completo

For Current Gilead Employees and Contractors:
**Job Description**:
Medical Review Physician

Patient Safety

**Responsibilities**:
- Reviews adverse event reports received for marketed and investigational products, adhering to standard operating procedures for medical assessment of individual case safety reports providing medical safety assessment and pharmacovigilance comment- Performs quality control (QC) of adverse event reports from a medical review perspective- Provides support to Coding Strategy group on an ad hoc basis- Provides medical consultation and training to GLPS Operations group including Literature Management and Autolabeling Management on an ad hoc basis- Makes contributions to process improvement within GLPS, particularly with adverse event processing and operational aspects of medical review- Provides Argus training and medical case review training to new medical review physician and oversees CRO medical review process as needed- Assists internal and external audit and inspection as needed

Essential Duties and Job Functions- Performs medical review of individual case safety reports (ICSRs) for investigational and marketed products- Supports Medical Review group with other ad hoc projects Knowledge, Experience and Skills- Requires an MD/DO degree or equivalent- Completion of an accredited medical or surgical residency program is required. Board certification is preferred- Demonstrates an excellent scientific/clinical and analytical knowledge base, with- ability to assess individual case safety reports and understand the safety/medical implications- Demonstrates independence in effectively managing projectsSpecific Education & Experience Requirements:
- 10+ years of expirence related life sciences field- Systems analyst experience, Drug Safety and clinical- Health care professional degree

**Qualifications**:
- Excellent interpersonal and communication skills, both written and oral- Excellent computer skills in Microsoft environment (Microsoft Excel, Power point and Word).- Safety database and data entry experience preferred- Understanding of medical terminology and the ability to summarize medical information required

For Current Gilead Employees and Contractors:

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