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Senior Manager, Global Case Management - Fixed-term maternity replacement

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Bucharest, Bucharest

  1. Research & Development
  1. Full-time
R00121105

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 XFacebookInstagramYouTubeLinkedIn and Tik Tok.


Job Description

The Senior Manager, Global Case Management supports the Global Safety Operations organization by overseeing the collection, preparation, processing, follow-up activities, submission and reporting of Individual Case Safety Reports (ICSRs) in compliance with global pharmacovigilance regulations.

Key Responsibilities:

  • Manage multifunctional responsibilities related to safety information and ICSR processing
  • Proactively identify and manage PV operational issues
  • Collaborate with Clinical development, Medical Affairs, and other strategic partners to ensure safety compliance
  • Monitor workflows to ensure cases are completed according to internal timelines to ensure compliance with regulatory guidelines and PV agreements.
  • Monitor compliance metrics and ensure adherence to standards and performance indicators
  • Support safety database and adverse event management applications, including technology project sponsorship

Qualifications

Main qualifications:

  • Bachelor's Degree or equivalent in a related science field; Advanced degree preferred
  • A minimum of 4 - 7 years of pharmaceutical industry experience in drug safety/pharmacovigilance required, with at least 4 years in global drug safety/pharmacovigilance including both investigational and marketed products
  • Extensive pharmaceutical industry experience, including pharmacovigilance and/or business operations
  • Familiarity with medical and clinical terminology, MedDRA, and drug safety databases (e.g., Argus, ARISg, or Clintrace) is essential
  • Proven direct line management experience with diverse teams
  • Global experience

Skills & Experience:

  • Team-building and relationship management expertise
  • Significant experience in leading cross-functional teams or complex projects.

Additional Information

Fixed-term maternity replacement position

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html