Literature Review Specialist (maternity replacement) Bucharest

Literature Review Specialist (maternity replacement)
Bucureşti
Bucharest, Bucharest, Romania

Job Description

Purpose:

This position supports the Literature and Vendor Management (LVM) 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, medical information, and product quality reports.

In addition, this individual will help shape our culture to help make a remarkable impact on Abb
Vie customers.

Responsibilities:

• Manages product safety aspects from literature articles:
  • Performs literature review for abstracts and articles received from different sources for Abb
    Vie’s products (all marketed products,
    - stage investigational products and relevant drug classes).
  • Identifies other safety information (which might be used in aggregate reports) and potential signals.
  • Manages ordering the relevant
    - text articles and translations.
  • Performs EMA MLM daily check.
  • Assists with document archiving, according to internal procedures and current naming conventions.
• Remains current on case processing conventions and regulations.
• Meets company standards for quality, compliance, and productivity.
• Exhibits the Abbvie core leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; All for One Abb
  Vie; Decide Smart and Sure.
• Other duties as assigned based on the needs or work requirements of the organization.

Education:

• Minimum: A degree with related health/life sciences background, RN, BSN, BS, BS Pharm. Candidates lacking the appropriate degree but with previous pharmaceutical experience may be considered.

Experience:

• 1-2 years of pharmaceutical industry experience, including a minimum of 1 year in global pharmacovigilance.
• Demonstrated ability to support project work.
• Ability to handle and prioritize multiple tasks.
• Preferred core knowledge of Industry regulations (ICH, FDA, EMEA, MHRA).