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About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Medical Safety Analyst

Romania Req ID 2206923 Category Research and Development Division AbbVie

Purpose of the role :
This position supports the case processing organization to achieve its mission of improving patient lives globally through industry leading safety and compliance by consistent and accurate delivery of high quality, relevant and timely adverse event information.
Responsibilities:

  • Collect, assess and process adverse event information (clinical and post marketing) in a compliant and timely manner in order to comply with global regulations which includes:   Seriousness assessment, Labeling, Causality,nitial and Follow - up
  •  Meeting company standards for quality, compliance and productivity. Remaining current on knowledge and skills required for case processing.
  • Meets case quality, case processing metrics and agility by exhibiting the Abbvie core leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; All for One AbbVie; Decide Smart and Sure.
  •  Supporting and participating in audits and inspections as needed.
  •  Other duties may be assigned based on the need or work requirement of the organization.
Qualifications:

Qualifications:

  • Bachelor's degree with related health science background preferred (pharmacy, biology, veterinary, etc Candidates lacking the appropriate bachelor’s degree but with previous pharma experience may be additionally considered.
  • Previous pharmacovigilance experience is not necessarily required.
  • Familiarity with medical and clinical terminology
  • Competent understanding of ICH/EMA/FDA regulations and guidelines affecting drug safety issues.
  • Able to apply clinical knowledge to adverse event data collection and assessment.
  • Sound understanding of product labeling, scientific literature, and drug safety profile.
  • Competent in ability to present adverse event data, orally and in writing.
  • Adheres to policies and regulations.
  • Must be Computer proficient (Windows, Outlook, Word, Excel, PowerPoint).
  • Must be fluent in English, oral and written communication
  • Excellent planning and organization skills, ability to handle and prioritize multiple tasks
  • Ability to work effectively in a team environment
  • Excellent analytical and decision-making skills
Travel: No
Job Type: Experienced
Schedule: Full-time
ABBVIE

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