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.
- Perform single case review of case for medical content & accuracy as assigned
- Confirm reportability
- Consult source documents as needed
- Prompt additional follow-up or queries
- Enter corrections to system as required
- Assist with surveillance activities including review of case series & frequency reports
- Oversee Workflow Management; use daily compliance report to monitor and prioritize work
- Provide education, training, and feedback to DSP resources
- Propose and lead improvement initiatives as assigned
- All DS Associate / Sr Associate responsibilities as time allows
- Manage and supervise assigned staff and Operations processes, incl
- Resource planning, recruiting, and performance management
- Training and development
- Work prioritization, resource allocation and delegation
- Issue resolution / escalation
- Ensure compliance with relevant policies and procedures
- Review group performance metrics
- Identify issues, analyze root causes, define improvement plans
- Establish goals in line with department strategies and monitor progress against them
RN, BSN, Nurse Practitioner, Pharmacist, Physician Assistant or related degree required.
Required Experience & Technical Requirements
Purdue Pharma L.P. and its associated U.S. companies are known for pioneering research on the principal cause of human suffering: chronic pain. Headquartered in Stamford, Connecticut, it is one of the fastest-growing pharmaceutical companies in the world today. Purdue Pharma has led the battle against inadequate treatment of pain by developing long-acting pain-control medications that are prescribed by healthcare professionals around the world. As the sponsor of Partners Against Pain, the company provides community outreach and educational programs to encourage the therapeutic alliance of patients, their families, caregivers, and healthcare professionals.
- Minimum 6 years of experience in a pharmaceutical company or clinical environment
- Minimum 4 years of Drug Safety experience required
- Advanced understanding of FDA and international regulations
- Advanced understanding of Purdue 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; basic understanding of regulatory dossier and controlled document applications
- 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 Preferred:
- Personnel management, including recruiting, coaching and training, evaluating performance, providing feedback, development planningBrief Description/Overview:
Benefits: Purdue offers a wide range of competitive benefits to all full-time employees. Our benefit package includes a variety of benefit programs to provide for the health, welfare and financial security of our employees and their families.
We are an Equal Opportunity Employer committed to a diverse workforce, M/F/D/V. Corporate standards require pre-employment drug testing and background investigation.
If you are interested in a specific open position, you must apply online by visiting our website at www.purduepharma.com. No hard copy resumes will be considered.
Purdue Pharma L.P. - 2 years ago