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Patient Safety Specialist I

Integrated Resources, Inc

Plainsboro Township, NJ

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JOB DETAILS
SALARY
JOB TYPE
Contractor
SKILLS
Adverse Events, Analysis Skills, Call Centers, Call Monitoring, Clinical Medicine, Clinical Nursing, Communication Skills, Corrective Action, Customer Escalations, Customer Support/Service, Data Entry, Detail Oriented, Diabetes, Disease, Distribution Management, English Language, FDA (Food and Drug Administration), Field Sales, Healthcare, Hemophilia, Identify Issues, Investigational New Drug (IND), Loyalty Programs, Maintain Compliance, Medical Dictionary for Regulatory Activities (MedDRA), Medical Records, Mentoring, Microsoft Excel, Microsoft Outlook, Microsoft Windows Operating System, Microsoft Word, Multilingual, Multitasking, Obesity, Organizational Skills, Patient Assessment, Patient Care, Patient Safety, Pharmacovigilance, Presentation/Verbal Skills, Procedure Development, Process Improvement, Product Marketing, Reconciliation, Record Keeping, Registered Nurse (RN), Safety Training, Safety/Work Safety, Scripting (Scripting Languages), Spanish Language, Telephone Triage, Time Management, Work From Home, Writing Skills
LOCATION
Plainsboro Township, NJ
POSTED
Today
Pay - $28.35/hr on w2 LOCATION: Plainsboro ONSITE (the worker can work from home few days/ weeks after discussion with the reporting manager, as needed) TARGET START DATE: ASAP DURATION: 6 months SCHEDULE: Mon-Fri 8:30a-5:00p (up to 40 hours/week) TOP 3 MUST HAVES: 1. A bachelors degree is required (preferably in a medical or science-related discipline); relevant experi-ence may be substituted for the degree when appropriate (e.g., a Registered Nurse with clinical experi-ence). 2. A minimum of 2 years of progressively responsible and relevant pharmacovigilance experience, includ-ing MedDRA coding and adverse event identification, is required. 3. Exceptional knowledge of medical and pharmacovigilance terminology is required PURPOSE Responsible for the receipt, processing, triage and quality assessment of all inbound safety information, including adverse events and technical complaints, client US marketed products (drugs and devices) and investigational products. Also responsible for ensuring compliance with all internal and external (e.g. FDA) drug and device safety reporting requirements regarding the collection and maintenance of safety records. RELATIONSHIPS Reports to Patient Safety Management. Daily internal interactions with personnel from Patient Safety , Medical Information, Field Sales, Customer Complaints Center, Suppliers and Patient Centric Customer Care. Daily external interactions with patients, caregivers, and health-care professionals. ESSENTIAL FUNCTIONS Ability to perform all responsibilities of more junior staff, including but not limited to: Processing of adverse events and associated technical complaints and analysis results related to marketed products into the local intake, complaint, and global safety databases, including but not limited to: Duplicate searches Product coding MedDRA coding Narrative generation Labeling assessment according to the current approved product label Receive inbound and make outbound calls for adverse events and technical complaints including han-dling of refund of replacement requests Perform data entry and review of adverse events and associated technical complaints and provide ongo-ing feedback regarding case quality to other case handlers to support their continued development and ensure excellent case quality Handle incoming and outgoing follow-up correspondence Collect and document information received during outbound follow-up calls Perform triage, case classification and case assignment Handle escalated calls for adverse events and technical complaints Assist with training of new hires; mentor new hires Perform reconciliations Assist with workload coordination/distribution Perform call monitoring Support the identification of trends and implementation of corrective actions for issues identified during case review Coordinate configuration requests for the safety and complaint databases Serve as Subject Matter Expert during audits/inspections for case handling Build customer loyalty by providing high quality customer service Provide professional, accurate and timely responses to product information questions and other inquir-ies using current approved product labeling and call scripts Identify procedural deficiencies and opportunities for process improvements; make improvement rec-ommendations to management and support implementation of solutions Assist with department related projects QUALIFICATIONS Bachelors degree required (in medical or science-related discipline preferred); relevant experience may be substituted for degree when appropriate (e.g. Registered Nurse with clinical experience). A minimum of 2 years of progressively responsible, relevant pharmacovigilance experience (including MedDRA coding and adverse event identification) required A minimum of 2 years of Customer Service experience preferred Exceptional knowledge of medical and pharmacovigilance terminology required Knowledge of NNI supported disease states preferred (e.g. diabetes, obesity, hemophilia, growth hor-mone disorders) Experience with audits/inspections preferred Analytical thinking skills required Proficiency in Windows, Microsoft Word, Excel and Outlook required Experience with a Call Center and Drug Safety database preferred Strong oral and written communication skills required Ability to work with sensitive or confidential information required Strong attention to detail required Ability to handle multiple priorities and demands in a fast-paced environment required Strong planning, organizational and time management skills required Ability to interact with various levels of the organization required Ability to form strong working relationships with stakeholders required Bi-lingual (Spanish-English) a plus

About the Company

I

Integrated Resources, Inc