Mgr., Drug Safety Operations
Location: Stamford Connecticut
Description: Purdue Pharma L.P. is looking of Mgr., Drug Safety Operations right now, this vacancy will be placed in Connecticut. More details about this vacancy opportunity please give attention to these descriptions. 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.
PRINCIPAL ACCOUNTABILITIES:
- 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 priori! tization, resource allocation and delegation
- Issue re! solution / 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
Technical Requirements
- 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 ski! lls 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
- Personnel management, including recruiting, coaching and training, evalua! ting performance, providing feedback, development planning
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.
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 Op! portunity 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.
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If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Purdue Pharma L.P..
If you interested on this vacancy just click on the Apply button, you will be redirected to the official website
This vacancy starts available on: Tue, 02 Jul 2013 02:27:28 GMT