- Decision maker for all reportability decisions
- Lead for all vigilance reporting, including local and global submissions
- Partners with pharmacovigilance, regulatory affairs, in-country teams, and device QA for submissions and escalates requests as appropriate
- Ensures that relevant stakeholders have visibility to the reporting and where they are in the process
- Manages regular reporting needs and external requests (i.e. from the FDA)
- Manage the timeline for end to end reporting
- Owns translation services for reporting
- Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
- Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.
- Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
- Solid written/verbal communication and organizational skills.
- Knowledge and application of computer systems for word processing and complaint management.
- Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
- 1+ year experience
- Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
- Solid written/verbal communication and organizational skills.
- Knowledge and application of computer systems for word processing and complaint management.
- Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
- Degree is preferred
- Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
- Clinical background including bio background, nursing, physicians from other countries without US practice has worked out as well.
-
Genetics Reporting Specialist
3 weeks ago
GoPath Laboratories Buffalo Grove, United States**Job description** · The Genetics Reporting Specialist will report to the Reporting Team Manager and will also work closely with the Director of Genetic Clinical Services and the Genetics Team (to include bioinformatics specialists and scientists) to prepare final genetics testi ...
-
Epic Reporting Specialist
2 weeks ago
UnitedHealth Group Kenosha, United StatesActing as a subject matter resource for Epics enterprise intelligence and analytics suite (e.g. clarity, reporting workbench, radar, slicer dicer, etc.) Implementing and/or expanding Epic based insights for client organizations Promoting Epic based r Specialist, Reporting, Health ...
-
Survey Report Specialist
3 weeks ago
Revenue Storm Schaumburg, United StatesThis role is for a Survey Specialist and Client Report Creator. The survey system we currently use is Qualtrics: for employee surveys, customer surveys, participant workshop evaluations, clients' sales challenge surveys that identifies where in the sales process they are struggli ...
-
Epic Reporting Specialist
1 week ago
UnitedHealth Group Kenosha, United StatesOptum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel ...
-
SAP Reporting Specialist
2 weeks ago
Zurich Insurance Company Ltd. Schaumburg, United StatesZurich North America is currently hiring an SAP Reporting Specialist and this person will work in a hybrid schedule at our Schaumburg, IL North America HQ. · Responsibilities: · Data Management: Manage and oversee the collection, analysis, and distribution of data using SAP softw ...
-
Curriculum Specialist
1 week ago
Boys & Girls Club of Lake County Waukegan, United States**Boys & Girls Club of Lake County - Curriculum Specialist** · The Boys and Girls Clubs of Lake County seeks a highly motivated and innovative Curriculum Specialist to plan, implement, supervise, and evaluate all curricula provided in program areas, focusing on achieving priority ...
-
Site Coordinator Special Rec Camp Sea
1 day ago
Waukegan Park District Waukegan, United States**Status of Employment**: · Seasonal, Non-Exempt · **Summer Camp Site Coordinator - Special Recreation** · **Hours**: · - Monday - Friday: Between the hours of 9am-4pm. · - Approximately 20-40 hours per week. · **Description**: · Provide supervision of seasonal Summer Day Camp Co ...
-
Bilingual Training Specialist
3 weeks ago
YWCA Metropolitan Chicago Gurnee, United States**POSITION TITLE**: Bilingual Training Specialist **STATUS**: Non-Exempt, FT **Grade**: 4 · **DEPT**:Early Childhood Services **PROGRAM**: Westside Provider Services*** · **Reports To**:Provider Services Coordinator **SUPERVISES**: NA · **SUMMARY**: In collaboration with the Prov ...
-
IT Support Specialist
3 weeks ago
Warren-Newport Public Library Gurnee, United States: · **Department**: Information Technology · **Reports To**: Head of Information Technology · **About Us**: We're a modern library providing exceptional services to our community. We're looking for a passionate IT Support Specialist to join our team and play a key role in keeping ...
-
IT Support Specialist
3 weeks ago
Abbott Laboratories Employees Credit Union Gurnee, United States**Summary**: Maintains ALEC's End User hardware and software by utilizing the IT Service Desk. The IT Support Specialist maintains user accounts, access levels, software and hardware. Works directly with other IT/IS representatives to secure, implement, and maintain ALEC's Inform ...
-
Recreation Manager
3 weeks ago
Warren Special Recreation Association Gurnee, United States**Job Purpose**: · The Recreation Manager is responsible for providing year-round special events (all ages), day trips (teen-adult) and general recreational programs and services (teen-adult) for individuals with disabilities. This position will have direct management of Inclusio ...
-
Developmental Specialist
2 weeks ago
YWCA Metropolitan Chicago Gurnee, United States**POSITION TITLE**: Developmental Specialist** STATUS**: Exempt, FT **GRADE**: 3 · **DEPT**: Early Childhood Services **PROGRAM**: Head Start · **REPORTS TO**:Mental Health Manager: Center Based** SUPERVISES**: N/A **SALARY**:$60K-$64K · **SUMMARY**: Assures the identification, s ...
-
Eligibility Specialist
4 days ago
YWCA Metropolitan Chicago Gurnee, United States**POSITION TITLE**: Eligibility Specialist **STATUS**: Non-Exempt, FT **GRADE**: 1 · **DEPT**: Early Childhood Financial Empowerment Services **PROGRAM**: Early Childhood Financial Empowerment · **REPORTS TO**: Early Childhood Financial Empowerment Services Coordinator · **SUPERV ...
-
Mortgage Resolutions Spec Lead
1 day ago
Old National Bank Gurnee, United StatesOverview: · - Old National Bank has been serving clients and communities since 1834. With $48 billion in total assets, we are a regional powerhouse deeply rooted in the communities we serve. As a trusted partner, we thrive on helping our clients achieve their goals and dreams, an ...
-
Billing Specialist
1 week ago
Burger King Gurnee, United StatesPay rate: $20-25/hour. · The Billing Specialist / Office Manager partners closely with MJG Enterprises executive leadership team to support day-to-day operations, accounts payable/receivable responsibilities and ad-hoc requests. · **Key Responsibilities**: · - Perform financial r ...
-
Communications Specialist III
1 week ago
US Tech Solutions Waukegan, United StatesPosition: Communications Specialist III · Location: North Chicago IL 60085 · Contract: 12 months with possible extension · In the Communications Specialist role, you will use your visual design and video storytelling skills to create compelling content that motivates employees in ...
-
Video Communications Specialist
4 days ago
Beacon Hill Waukegan, United StatesAdditional skills that would make you an exceptionally strong candidate: · Current SharePoint or web design / CMS skills · Scriptwriting experience · Tools and technologies used in this role: · Adobe Premiere or Camtasia for video editing · Adobe Creative Suite or Canva for graph ...
-
Video Communications Specialist
3 days ago
Beacon Hill Waukegan, United StatesAdditional skills that would make you an exceptionally strong candidate: · Current SharePoint or web design / CMS skills · Scriptwriting experience · Tools and technologies used in this role: · Adobe Premiere or Camtasia for video editing · Adobe Creative Suite or Canva for graph ...
-
Scientist
3 weeks ago
Randstad Life Sciences US North Chicago, United StatesTitle: Spatial Profiling Specialist · Location: North Chicago, IL · Contract: 9+ months · Pay: 35-47/hr · Summary · In 2016 we created an internal research group, the Genomics Research Center (GRC) within Discovery R&D. The GRC is a single organization that supports and drives ge ...
-
Senior Electrical Engineer
1 week ago
Naval Facilities Engineering Systems Command (NAVFAC) Shields, United StatesJoin one of the Navy's largest Commands as a Civilian toMaximize Naval Shore Readiness and Strengthen our Team We offer competitive benefits, retirement package, paid leave, and other exciting opportunities · *********************************************************************** ...
Medical Product Reporting Specialist - North Chicago, United States - Collins Consulting Inc
Description
This is a hybrid position, 3 days onsite and 2 days remote. (Start times are flexible after training)Job Description:
If candidate has preferred qualification of Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211), that is a plus.
Purpose:
The Reporting Specialist I is responsible for executing all of the reporting, in partnership with internal and external stakeholders. The individual will also partner with internal teams such as pharmacovigilance, local in-country teams, and the device quality assurance team to ensure the appropriate and accurate reporting of complaints. They will interface with regulators and serve as the liaison to the respective team when questions and requests arise.
Responsibilities:
Qualifications:
Years of experience/education and/or certifications required:
What are the top 3-5 skills requirements should this person have?
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?