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Stamford, Connecticut
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Description: Position supports the Director in leading the Drug Safety Operations function. Manages assigned staff in performing Case Management responsibilities. Contributes innovative ideas and implementation plans for further development and improvement of drug safety processes.
Mgr/Sr Mgr. will manage and supervise assigned staff and Operations processes, including resource planning, recruiting, and performance management; training and development; work prioritization, resource allocation and delegation; and issue resolution / escalation. They perform single case review of case for medical content & accuracy, as assigned and assist with surveillance activities including review of case series & frequency reports. They will oversee Workflow Management; use daily compliance reports to monitor and prioritize work for the Case Management function. They will propose and lead improvement initiatives as assigned. The individual will ensure compliance with relevant policies and procedures; review group performance metrics, identifying issues, analyzing root causes, and defining improvement plans. They will assist the Director in establishing goals in line with department strategies and monitoring progress against them.
Educational Requirements: Manager:
RN, BSN, Nurse Practitioner, Pharmacist, Physician Assistant or related bachelor-level degree required.
Senior Manager:
RN, BSN, Nurse Practitioner, Pharmacist, Physician Assistant or related bachelor-level degree required. Required Experience & Technical Requirements Manager:
- Minimum 6 years of experience in a pharmaceutical company or clinical environment
- Minimum 4 years of Drug Safety experience required
- At least 1 year Managerial experience in a Drug Safety environment with Personnel management, including recruiting, coaching and training, evaluating performance, providing feedback, development planning strongly preferred
Senior Manager:
- Minimum 7 years of experience in a pharmaceutical company or clinical environment
- Minimum 5 years of Drug Safety experience required
- Minimum 3 yr managerial experience required, Drug Safety environment strongly preferred
For both levels:
- Advanced understanding of FDA and international regulations
- Advanced understanding of company's processes (including relevant SOPs, WPDs), documentation, requirements, and organization
- Product knowledge (labeling, therapeutic class)
- Data entry and computer skills
- Advanced skills with Argus and basic MS Office applications, and eDocs; basic understanding of RADocs, GRASP
- Working knowledge of scientific terms and medical terminology
- Working knowledge of MedDRA
- Written and verbal communication skills; interpersonal skills
- Organization skills; analytical thinking
- Time management and ability to prioritize workload (self and others)
- Quality orientation: attention to detail, accuracy
- Meeting facilitation
- Working knowledge of Project Management
- Advanced understanding of safety processes
- Ability to apply Drug Safety / Clinical experience in AE assessment
- Advanced understanding of documentation requirements in a regulated environment
- Ability to influence others
- Understanding of training concepts
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