This position will support the Drug Safety and Pharmacovigilance in all coding and dictionary management activities for the Drug Safety and Pharmacovigilance department. This self-starter individual will serve as a medical and drug encoding expert, providing user guidance on adverse event coding and data retrieval in accordance with the best practices for the application of the MedDRA and WHO-Drug terminologies. This position will involve ownership and maintenance of coding standards, strong collaboration with the Drug Safety Medical group, business lead representation on dictionary/coding application validation, leading efforts in coding quality assurance and related training delivery as needed. PRINCIPAL ACCOUNTABILITIES: • Establish and maintain medical coding standards used across Purdue R&D and the Independent Associated Companies -Drug Safety Centers (IAC-DSC). • Establish and maintain consistent coding of adverse events to ensure retrieval of specific cases or medical conditions from the database, through review of all DSP coding output, daily for correctness of medical concept and consistency. Ensure coding follows DSP and company coding guidelines • Review and update safety plans, data management plans, coding plans and guidelines for accuracy as related to medical coding for use by clinical studies. • Provide functional oversight of DSP staff and designated MR/CRO staff for compliance to coding plans and guidelines used across clinical studies and assist with SAE reconciliation. • Generate coding criteria for medical concept database queries and works with Drug Safety Medical physicians to ensure accuracy and completeness. • Support DSP Study Team Representatives activities for ensuring compliance to safety plans, data management plans, coding plans, guidelines, protocols and relevant project management plans as identified by the DSP Study Team Representative. • Serve as designee for the Medical Coding Expert and secondary point of contact with external terminology license organizations. • Represent DSP as the Business Lead on the validation of any medical dictionary/coding applications used within Purdue R&D. • Develop and deliver training on relevant coding topics to DSP and Medical Research. • Serves as coding guidance contact for questions from DS&P colleagues, communicating coding inconsistencies. • Perform safety data recoding as identified to support evolving business practices and/or dictionary versioning. • May provide assistance in other Drug Safety Operations tasks as requested by the Director, Drug Safety Operations, and/or Department Head to ensure the company's compliance with all FDA and ICH regulations and guidelines governing the reporting of adverse events.
Bachelor's degree or higher, life sciences, nursing, pharmacy or related field, or in lieu of degree, minimum eight years' experience in clinical research, data and/or medical records encoding and certification are acceptable.
Required Experience & Technical Requirements
Technical Requirements • Minimum of 6 years' pharmaceutical industry or equivalent CRO experience in coding of adverse events in post marketing drug safety and surveillance, and/or clinical trials required • Minimum of 4 years' experience with the Medical Dictionary for Regulatory Activities (MedDRA) with strong knowledge of WHO Drug Dictionary and ICH guidelines • Minimum of 3 years' experience with reviewing coding reports and identifying inconsistencies as related to dictionary coding. • Strong knowledge of best practices related to MedDRA coding of patient data required. • Ability to effectively interpret, assess, and communicate medical/scientific data • Working knowledge of scientific terms and medical terminology • Data entry and computer skills • Proficiency with basic MS Office applications and relational safety and/or clinical databases • Written and verbal communication skills; interpersonal skills • Organization skills; analytical thinking • Presentation skills • Time management and ability to prioritize workload • Quality orientation: attention to detail, accuracy • Working knowledge of FDA and international regulations • Understanding of documentation requirements in regulated environment • Detailed understanding of safety processes • Working knowledge of ARGUS Safety database preferred
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 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. - 11 months ago