Global Case Management Associate
2 weeks ago
*This position is onsite in Ridgefield, CT & remote*Currently seeking a Global Case Management Associate (GCM) to join our Patient Safety & Pharmacovigilance (PSPV) team located at our Ridgefield, CT facility. The GCM will provide case processing and auditing support. Duties & Responsibilities: Daily submissions of follow-up queries to appropriate adverse event reporters and QC of follow-up queries Deliverables: GCM associates are responsible for sending follow-up queries to US domestic reporters of adverse event reports. These queries are usually sent to provide further information, updates, or requests related to previously submitted adverse event reports. Additionally, GCM associates review queries initiated in the safety database to ensure that the purpose of the follow-up is communicated in a professional manner. Responsibilities - The GCM team is responsible for initiating follow-up query requests, but the submission of these requests is supported by the Global Case Management Associate in PSPV. Daily review of correspondence module in the safety database to monitor responses to follow-up queries received from adverse event reporters Deliverables: On a daily basis, GCM associates review the correspondence module in the safety database to monitor responses received from adverse event reporters regarding follow-up queries. After confirming that responses to follow-up requests have been received, the queries are closed in the global safety database. Responsibilities - Monitoring these responses to queries daily and taking appropriate actions are tasks performed independently by the Global Case Management Associate. Conducting and supporting various reconciliation-related tasks including reconciliation of Investigator Initiate Studies, License Partner's information and Product Complaints Deliverables: Support GCM associates perform reconciliation tasks by comparing and analyzing the data from various sources, such as Investigator Initiated Studies, License Partner's information and Product Complaints, documenting the results, discrepancies and taking appropriate actions for each data source. Responsibilities - PSPV teams and/or License Partners provide reconciliation reports to perform the reconciliation of these sources. The global Case Management Associate in PSPV supports the reconciliation process for these sources with GCM's oversight. Support IND submission-related activities. Deliverables: Perform activities supporting the fulfillment of PSPV's expedited reporting obligations to US FDA. Responsibilities - Ensure IND safety reports are uploaded in the correct format for Regulatory Affairs (RA). Ensure submissions performed by RA are properly documented in the safety system. This task is performed independently by the Global Case Management Associate in PSPV. Veeva review. Deliverables: Daily review of Veeva reports for potential AEs. Responsibilities - Independently review comments in Veeva for potential AE reports. Act on any potential report in a timely manner or seek clarification when needed from the source of the comment. Support ad hoc departmental projects and activities as they relate to the organizational components of ICSR processing. Deliverables: GCM associates support ad hoc departmental projects and activities related to the organizational components of ICSR processing. Experience and Skills Requirements: 4 Year college degree 2+ years of case report processing and auditing experience Project management and administrative skills Medical and clinical terminology Strong communication skills Proficiency in computer skills, with direct working experience in multiple electronic platforms MS Office skills Job Type: Full-time Hybrid position Ridgefield, CT
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Global Case Management Associate
5 days ago
Ridgefield, United States McInnis Inc. Full time*This position is onsite in Ridgefield, CT & remote*Currently seeking a Global Case Management Associate (GCM) to join our Patient Safety & Pharmacovigilance (PSPV) team located at our Ridgefield, CT facility. The GCM will provide case processing and auditing support.Duties & Responsibilities:Daily submissions of follow-up queries to appropriate adverse...
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Global Case Management Associate
1 month ago
Ridgefield, United States McInnis Inc. Full time*This position is onsite in Ridgefield, CT & remote*Currently seeking a Global Case Management Associate (GCM) to join our Patient Safety & Pharmacovigilance (PSPV) team located at our Ridgefield, CT facility. The GCM will provide case processing and auditing support.Duties & Responsibilities:Daily submissions of follow-up queries to appropriate adverse...
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Global Case Management Associate
3 weeks ago
Ridgefield, United States McInnis Inc. Full time*This position is onsite in Ridgefield, CT & remote* Currently seeking a Global Case Management Associate (GCM) to join our Patient Safety & Pharmacovigilance (PSPV) team located at our Ridgefield, CT facility. The GCM will provide case processing and auditing support. Duties & Responsibilities: Daily submissions of follow-up queries to appropriate...
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Global Case Management Associate
2 weeks ago
Ridgefield, United States McInnis Inc. Full time*This position is onsite in Ridgefield, CT & remote*Currently seeking a Global Case Management Associate (GCM) to join our Patient Safety & Pharmacovigilance (PSPV) team located at our Ridgefield, CT facility. The GCM will provide case processing and auditing support.Duties & Responsibilities:Daily submissions of follow-up queries to appropriate adverse...
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Global Case Management Associate
1 month ago
Ridgefield, United States McInnis Inc. Full timeJob DescriptionJob Description*This position is onsite in Ridgefield, CT & remote*Currently seeking a Global Case Management Associate (GCM) to join our Patient Safety & Pharmacovigilance (PSPV) team located at our Ridgefield, CT facility. The GCM will provide case processing and auditing support. Duties & Responsibilities: Daily submissions of follow-up...
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Global HEOR Lead, Retinopathies
1 day ago
Ridgefield, United States BioCT Innovation Commons Full timeCompensation Data This position offers a base salary typically between $183,000 and $280,000. The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits please click here. Description As an employee of Boehringer Ingelheim, you will actively contribute to the...
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Hospice Registered Nurse Case Manager
8 hours ago
Ridgefield, United States RVNAhealth Full timeJob DescriptionJob DescriptionWhy RVNAhealth?RVNAhealth (formerly known as RVNA, the Ridgefield Visiting Nurse Association) is an eleven-time winner of the Hearst Media Top Workplaces Award. We offer rewarding career opportunities where you can make an enormous impact.This position will cover Southern Fairfield County (Stamford/Greenwich)Benefits of Working...
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Associate Director, Medical Coding, Analytics
13 hours ago
Ridgefield, United States Boehringer Ingelheim Pharmaceuticals Full timeDescriptionAs an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize...
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Associate Director, Consumer
12 hours ago
Ridgefield, United States Boehringer Ingelheim Pharmaceuticals Full timeDescription This role is based on-site at our Ridgefield, CT location with hybrid flexibility of 2-3 days per week on-site. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate...
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Ridgefield, United States Boehringer Ingelheim Full timeDescription The (Senior Associate) Director will join our motivated and expert team of physicians in the global Cardio-metabolism/Respiratory Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of our patients worldwide. This is a highly visible role for an individual with a strong medical/scientific background...
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Clinical Administrative Associate
4 weeks ago
Ridgefield, United States McInnis Inc. Full time*This Position is onsite in Ridgefield, CT* Currently seeking a Clinical Associate (CA) to join our Study Management & Conduct (SM&C) team located at our Ridgefield, CT facility. The CA will provide administrative operational support to Clinical Operations (CO) for trial-related activities and processes in the operational planning, implementation, conduct,...
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Clinical Administrative Associate
1 month ago
Ridgefield, United States McInnis Inc. Full timeJob DescriptionJob Description*This Position is onsite in Ridgefield, CT*Currently seeking a Clinical Associate (CA) to join our Study Management & Conduct (SM&C) team located at our Ridgefield, CT facility. The CA will provide administrative operational support to Clinical Operations (CO) for trial-related activities and processes in the operational...
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Clinical Administrative Associate
1 month ago
Ridgefield, United States McInnis Inc. Full time*This Position is onsite in Ridgefield, CT*Currently seeking a Clinical Associate (CA) to join our Study Management & Conduct (SM&C) team located at our Ridgefield, CT facility. The CA will provide administrative operational support to Clinical Operations (CO) for trial-related activities and processes in the operational planning, implementation, conduct,...
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Clinical Administrative Associate
2 days ago
Ridgefield, United States McInnis Inc. Full timeThis Position is onsite in Ridgefield, CT Currently seeking a Clinical Associate (CA) to join our Study Management & Conduct (SM&C) team located at our Ridgefield, CT facility. The CA will provide administrative operational support to Clinical Operations (CO) for trial-related activities and processes in the operational planning, implementation, conduct, and...
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Clinical Administrative Associate
4 weeks ago
Ridgefield, United States McInnis Inc. Full time*This Position is onsite in Ridgefield, CT*Currently seeking a Clinical Associate (CA) to join our Study Management & Conduct (SM&C) team located at our Ridgefield, CT facility. The CA will provide administrative operational support to Clinical Operations (CO) for trial-related activities and processes in the operational planning, implementation, conduct,...
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Ridgefield, United States BI Pharmaceuticals, Inc. Full timeReview promotional claims and materials for BI Rx drug promotion for compliance with Food Drug Cosmetic Act (FDCA) and for consistency with product labeling. Participate in Human Pharmaceutical Review Committee, providing regulatory opinion on promotional communications. Review scientific exchange communications that require HPRC approval to ensure they are...
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Associate Director/Sr. Associate Director
1 month ago
Ridgefield, United States Boehringer Ingelheim Pharmaceuticals Full timeDescription The Associate Director/Sr. Associate Director, Cardiovascular-Renal Sales is responsible for the Sales team within the assigned geography in the US. This includes the development of the district level CRM business plan and implementation of the BIPI sales/marketing plan to assure optimal market penetration of BIPI and co-promoted products within...
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Associate Director, Information Management
7 days ago
Ridgefield, United States BI Pharmaceuticals, Inc. Full timeThis role supports the US Brand teams, HP Operations, Value & Access Solutions and Sales teams in identifying consent and preference requirements, translating them into requirements, creating implementation plans, and delivering consent and preference management and oversight that allows these teams to comply with legal and privacy requirements while meeting...
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Director, Medical Safety Physician
1 day ago
Ridgefield, United States Boehringer Ingelheim Full timeDescription The Medical Safety Physician will join our motivated and expert team of physicians in the global Oncology Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of our patients worldwide. This is a highly visible role for an individual with a strong medical/scientific background who is inspired by...
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Manager, Reg Affairs NAM
7 hours ago
Ridgefield, United States IFF Family of Companies Full timeRequisition ID : 500985 Job Description We are searching for a candidate to provide North America (including US and Canada) regulatory support for IFF Health and Biosciences business unit with focus on dietary supplement ingredients. The successful candidate will work as part of a global regulatory team within IFF Health and collaborate with internal...