(Senior) Medical Safety Analyst Bucharest

(Senior) Medical Safety Analyst
Bucureşti
Bucharest, Bucharest, Romania

Job Description

This position supports the case processing organization to achieve its mission of improving patient lives
globally through consistent and accurate delivery of high quality, relevant, and timely adverse event
management by providing effective oversight of external providers of Pharmacovigilance services for
Abb
Vie.

Responsibilities:

• Conducting oversight of vendors to ensure collection, assessment, and processing of adverse event information (clinical and post marketing) is performed in a compliant and timely manner to comply with global regulations including:

1. Seriousness assessment
2. Labeling
3. Causality
4. Initial and Follow-up

• Conducting oversight of vendors to ensure company standards for quality, compliance and
• productivity are met. Remaining current on knowledge and skills required for case processing.
• Supporting vendor case quality, case processing metrics and agility using the Abb
  Vie core
• leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; All
• for One Abb
  Vie; Decide Smart and Sure.
• Supporting and participating in audits and inspections as needed.
• Developing knowledge and expertise to initiate mentoring of MSA’s in vendor management.
• Supporting development of materials and delivering training in conjunction with the vendor,
• including
  -
  - trainer,
  - topics, refresher, and internal Abb
  Vie trainings as needed.
• Other duties may be assigned based on the need or work requirement of the organization.

• Bachelor’s degree in Life Science.
• 2-4 years clinical experience or 2-3 years clinical experience and 1-year pharmacovigilance experience.
• Demonstrates ability to lead project work. Proven success in
  - driven process management.
• Demonstrates ability to work collaboratively in team environment.
• Demonstrates understanding of the changing regulatory environment and impact to case
• management process
• Core knowledge of industry regulations (ICH, FDA, EMEA, MHRA).
• Competent in case processing, procedures, conventions.