Specialist, Reporting I

3 weeks ago

Branchburg, United States AbbVie, Inc Full time

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

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

* Decision maker for 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

Qualifications

Qualifications

* Bachelor's Degree strongly preferred; preferably in the life sciences, pharmacy, nursing, or other scientific background
* 5+ years of work experience in a cGMP related industry or in a clinical setting (preferred)
* 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.

Additional Information

Applicable only to applicants

  • Cultivation Specialist

    11 hours ago

    Branchburg, United States Verano Full time $17

    Have you been waiting to get into something that's more than a job? This is the moment you start your career with Verano!At Verano, we pride ourselves on being market leaders and for constantly challenging the status quo.Join us and become a part of something different – a close-knit team of energetic and committed peers; a group of individuals who...

  • QA Inspector I

    7 days ago

    Branchburg Twp, United States Amneal Pharmaceuticals Full time

    Job Summary The QA Inspector I monitors and ensures all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established specifications. The QA Inspector I must monitor and ensure all phases of drug manufacturing are in compliance with established...

  • Principal Validation Specialist

    3 weeks ago

    Branchburg, United States Roche Full time

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Quality Systems Analytics Specialist,

    8 hours ago

    Branchburg Twp, United States AbbVie Full time

    Job Description We are looking for a skilledQuality Systems Analytics Specialist to join our team at the Branchburg site. This position offers a unique opportunity to lead and develop a data-driven culture within our quality organization and site, reporting directly to the Executive Director of quality. As the Quality System Analytics Specialist, you will...

  • Quality Systems Analytics Specialist,

    5 hours ago

    Branchburg Township, United States AbbVie Full time

    Job DescriptionJob DescriptionCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and...

  • Manufacturing Equipment Validation Specialist/Engineer

    1 month ago

    Branchburg, United States Roche Full time

    The Position At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming...

  • Boiler Operator

    11 hours ago

    Branchburg, United States Verano Full time $25

    At Verano, we pride ourselves on being market leaders and for constantly challenging the status quo.Join us and become a part of something different – a close-knit team of energetic and committed peers; a group of individuals who will constantly challenge you to grow and express yourself. You’ll be guided by an experienced, engaged, and accessible...

  • Automation Lead

    10 hours ago

    Branchburg, United States Verano Full time $20

    Have you been waiting to get into something that's more than a job? This is the moment you start your career with Verano!At Verano, we pride ourselves on being market leaders and for constantly challenging the status quo.Join us and become a part of something different – a close-knit team of energetic and committed peers; a group of individuals who will...

  • Warehouse Associate

    2 days ago

    Branchburg Twp, United States Specialty Building Products Full time

    Specialty Building Products is a people first organization. U.S. LUMBER GROUP is an SBP Brand. You may be wondering, why should I join Specialty Building Products? We live our Core Values and they reflect what we actually believe and how we actually behave. They are who we are. You are joining a team that is built upon a strong culture and standards for...