(Senior) Medical Safety Analyst
(Senior) Medical Safety Analyst
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
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
AbbVie.
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:
- Seriousness assessment
- Labeling
- Causality
- 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 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.
- Developing knowledge and expertise to initiate mentoring of MSAs in vendor management.
- Supporting development of materials and delivering training in conjunction with the vendor
- including train-the-trainer special-topics refresher and internal AbbVie trainings as needed.
- Other duties may be assigned based on the need or work requirement of the organization.
Qualifications :
- Bachelors 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 results-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.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
