Senior Medical Safety Analyst

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:

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 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 MSA’s 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.

• 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 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.

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 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

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, AbbVieGlobal%2F&data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=pxrMl8T5PQl8HU8Xhph7jSamZXR%2Fqlh%2FTMIodipTPfs%3D&reserved=0">Facebook, Instagram, AbbVie&data=05%7C01%7Cjulia.jackson%40abbvie.com%7Ccbb826c15f604428c9e108db9e8141cb%7C6f4d03de95514ba1a25bdce6f5ab7ace%7C0%7C0%7C638278050214166646%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=%2Fz0FnNhXfkO2DHSZdZ2mGo6WQ1oEyKQTGDujo0hZDoQ%3D&reserved=0">YouTube, LinkedIn and Tik Tok.

Originally posted on Himalayas