About this role
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 incountry
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 decisionsLead for all vigilance reporting, including local and global submissionsPartners with pharmacovigilance, regulatory affairs, in-country teams, and device QA for submissions and escalates requests as appropriateEnsures that relevant stakeholders have visibility to the reporting and where they are in the processManages regular reporting needs and external requests (i.e. from the FDA)Manage the timeline for end to end reportingOwns translation services for reporting Bachelor’s Degree strongly preferred; preferably in the life sciences, pharmacy, nursing, or other scientific background5+ 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. At AbbVie, we are committed to cultivating a workplace culture that promotes inclusion, diversity, and personal growth. We recognize that our collective success is based on the individual well-being of our employees, which is why we have designed a benefits package that considers every aspect of their lives.
Enhanced Health and Wellness Coverage: Our administrative staff enjoys comprehensive medical and dental insurance, ensuring peace of mind for you and your loved ones. Extended Vacation: We believe in the balance between work and personal life for our administrative team. That’s why we offer additional vacation days, beyond legal requirements. Flexible Hybrid Work Model: For eligible positions within our administrative staff, we have adopted a hybrid work scheme allowing the convenience of working from home two days a week.Life Insurance: Secure your family’s future with our life insurance policy. Employee Assistance Program (EAP): Access professional support with our comprehensive EAP, offering psychological, legal, and financial counseling.On-Site Health Services: Benefit from the convenience of having a company doctor and physical therapy services, demonstrating our commitment to your health and well-being. Community and Social Engagement: Make a difference with a paid volunteer day, allowing you to contribute to the community during company working hours. Special Leave Benefits: Celebrate your life achievements with extra leave days for marriage and enjoy your birthday with a day off. Employee Stock Purchase Plan: Participate in our company's success by purchasing shares at a special price exclusive to employees. Transportation and Meals subsidized. Solidary Association: Join a community focused on mutual help and enjoy the benefits that come with being a member.AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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