Vigilance Specialist (m/f/d)
JOB DESCRIPTION:
About Abbott
Abbott is a global health care leader , creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
In Germany, Abbott has approximately 4,000 employees working in manufacturing, research and development, logistics , manufacturing, sales and marketing. They are located at Abbott`s German headquarters in Wiesbaden and its sites in Neustadt am Rübenberge , Wetzlar, Eschborn, Cologne, Jena , Hamburg and Munich.
The Opportunity
This position works out of our Wiesbaden-Delkenhein Abbott GmbH location.
Primary Function
- Member of International Vigilance team responsible for Vigilance reporting to European competent authorities and/ or Notified Bodies
- Supports activities in all Vigilance reporting related matters for Abbott Core and Molecular Diagnostics businesses
Major Responsibilities
- Reporting of Medical Events, Trend Reports, Periodic Summary Reports and Field Safety Corrective Actions (=Vigilance Reporting) and PMS related reports to Competent Authorities and Notified Bodies as required within European Economic Area (EEA), UK, Switzerland &Turkey for Abbott Core and Molecular Diagnostic businesses products (IVD&MD) according to shared service agreements
- Supports global Vigilance reporting for World Health Organization (WHO) prequalified and WHO emergency use listed products of Core Diagnostic business, as required.
- Processing of requests from Competent Authorities and other Regulatory Bodies by consolidating information from internal contacts and submitting final responses according expected timeline
- Support in maintaining procedures and processes for the International Vigilance team and international vigilance contacts.
- Support of audits for Vigilance reporting related requests, as required
- Stay up to date on vigilance related regulation and guidelines applicable for EEA countries, UK, Switzerland &Turkey.
Education
- Solid scientific background (Degree in Medicine, Biology, Chemistry or Similar)
Background
- Experience in diagnostic and/or drug industry is welcomed
- Experience of work in an international working environment, on international projects or work experience in foreign country is welcomed
- Good English skills (experienced level required, negotiation level preferred); At least one more European language is preferred
- Knowledge of PC- and internet-based applications
W orking at Abbott
At Abbott, you can do work that matters and help people to live a healthier and full life, grow your career, and learn, be your true self. You will have access to:
- Career development with an international company where you can grow the career you dream of
- An attractive benefits package ( e.g. attractive Abbott Pension Plan , a company bike, employee stock purchase program)
- A company r ecognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
- A challenging position in a fast-growing crisis independent industry
- To become part of a dynamic, highly educated, highly skilled, and motivated team
- Flat hierarchies, open appreciative mentality, and efficient, constructive lines of communication
- Multi-national environment, where we foster the development of our talents within the enterprise
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
We ask for your understanding that we only consider online applications via our online application portal. Applications by email or post cannot be processed. Original documents will not be returned.
Connect with us at www.abbott.com , on LinkedIn at https://www.linkedin.com/company/abbott-/
The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
CRLB Core Lab
LOCATION:
Germany > Wiesbaden-Delkenheim : G01
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable