Senior Manager, Global Case Management - Fixed-term maternity replacement
Job Description
The Senior Manager, Global Case Management supports the Global Safety Operations organization by overseeing the collection, preparation, processing,
- 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, Med
DRA, 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
- functional teams or complex projects.
Fixed-term maternity replacement position
Abb
Vie 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 Abb
Vie’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
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