compensation: . employment type: contract job title: Case Processing Associate
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CASE PROCESSING ASSOCIATE
This is a Remote position.
• Responsible for the receipt, processing, triage and quality assessment of all inbound safety information including adverse events and technical complaints for the Client’s US marketed products (drugs and devices).
• 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 information.
• 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 Client products into the complaint and global safety databases, including but not limited to:
o Duplicate searches.
o Product coding.
o MedDRA coding.
o Narrative generation.
• Labeling assessment according to the current approved product label.
• Receive inbound and make outbound calls for adverse events and technical complaints including handling of refund of replacement requests.
• Manage all outbound letters and inbound letters.
• Collect and document information received during outbound follow-up calls.
• Generate acknowledgement and follow-up letters.
• Perform triage, case classification and case assignment.
• Perform reconciliations.
• Perform quality check of adverse events and associated technical complaints including a review of the case complaint and safety descriptions for completeness, and evaluation and confirmation of case seriousness, review of coding of products, medical history, indications and adverse events, and the final quality check of all case content.
• Provide ongoing feedback regarding case quality to case handlers to support their continued development and ensure excellent case quality.
• Assist with workload coordination.
• Build customer loyalty by providing high quality customer service.
• Provide professional, accurate and timely responses to product information questions and other inquiries using current approved product labeling and call scripts.
• Identify procedural deficiencies and opportunities for process improvements; make improvement recommendations to management and support implementation of solutions.
• Assist with department related projects.
• Reports to Product Safety Management.
• Daily internal interactions with personnel from Product Safety, Medical Information, Field Sales, Customer Complaints Center, and Patient Centric Customer Care.
• Daily external interactions with patients, caregivers, health-care professionals, and external vendors.
• Bachelor’s degree required (in medical or science-related discipline) or equivalent industry experience.
• Strong knowledge of medical and pharmacovigilance terminology required.
• Safety Experience (identifying safety information and data entry of safety cases in safety systems).
• Phone experience - This is a must as they will be making calls and receiving calls (customer service- could be pharmacy tech. or PV Phones).
• Analytical thinking skills required.
• Proficiency in Windows, Microsoft Word, Excel, and Outlook required.
• 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.
• Team attitude – someone who can see that we are all a team, and we are all in this together.
• A minimum of 2 years of progressively responsible, relevant pharmacovigilance experience Safety (including MedDRA coding and adverse event identification) preferred.
• Experience with a Call Center and Drug Safety database preferred.
• A minimum of 2 years of Customer Service experience preferred.
• Knowledge of the Client’s supported disease states preferred (e.g., diabetes, obesity, hemophilia, growth hormone disorders).
• Experience with audits/inspections preferred.
• Bi-lingual (Spanish/English) a plus.
This 12+ month position starts ASAP.
ALPHA’S REQUIREMENT #22-01709
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
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