Drug Safety Associate
Location: Stamford Connecticu! t
Description: Purdue Pharma L.P. is at present looking to employ Drug Safety Associate right now, this position will be placed in Connecticut. More details about this position opportunity please read the description below. The Drug Safety Associate will primarily perform triage on all case types and determine labeling and case assessment to determine prioritization, performing duplicate case searches and enter basic case data. They initiate critical follow-up requests, consult / collaborate with internal colleagues and external departments. They are involved in the clinical research activities, representing DS Operations on clinical study teams. The Associate will also participate in development and review of content for conventions, SOPs and WPDs. This role also supports data entry wh! en required, processing all case types to meet compliance requ! irements.. S/he will identify adverse events, seriousness, and listedness / labeledness for case completion. S/he will identify potential product complaints to forward to that function and perform all appropriate coding and write case narratives for adverse events. The Associate will determine follow-up requirements, and formulate and generate queries. The individual would also perform own QC of reports and perform reconciliation of clinical Serious Adverse Events. They should also expect to contribute to production of Periodic Safety Update Reports with Case Management activities. Required skills: Detailed understanding of safety processes Argus Safety knowledge Sound working knowledge and ability in primary discipline and familiarity with related disciplines; independently follows established procedures; troubleshoots and develops solutions to routine problems of limited scope Ability to apply clinical exp or DS experience in adverse event assessment Advanced understandin! g 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; Proficiency with basic MS Office applications; Written and verbal communication skills; interpersonal skills; Organization skills; analytical thinking; Time management and ability to prioritize workload; Working knowledge of scientific terms and medical terminology; Basic knowledge of MedDRA; Understanding of documentation requirements in regulated environment
Educational Requirements
RN, BSN, Nurse Practitioner, Pharmacist, Physician Assistant or related degree required, or Associates degree in a relevant field with commensurate Purdue Drug Safety experience.
Required Experience & Technical Requirements
Technical Requirements 3 - 5 years of experience in a pharmaceutical company or clinical environmen! t required; minimum 2 years Drug Safety experience required.
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 Opp! ortunity 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 position, please email us your resume, with salary requirements and a resume to Purdue Pharma L.P..
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This position starts available on: Wed, 01 Jan 2014 15:37:01 GMT