Senior Medical Safety Analyst
- Employer
- AbbVie
- Location
- Lake County, IL, US
- Start date
- May 24, 2019
View more
- Discipline
- Administration, Clinical, Drug Safety/Pharmacovigilance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioMidwest, Best Places to Work
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Job Details
- 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, Initial and Follow up
- Meeting company standards for quality, compliance and productivity. Remaining current on knowledge and skills required for case processing.
- Understanding of the changing regulatory environment and the impact to the case management process.
- 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
- Grows knowledge and expertise to initiate mentoring opportunities of other MSA's in case processing in their primary area PMS or Clinical.
- Other duties may be assigned based on the need or work requirement of the organization.
Level of position is commensurate upon education and experience of the candidate.
- Minimum: Bachelor's degree with related health sciences background, RN, BSN, BS, BS Pharm.
- Candidates lacking the appropriate degree but with previous pharmaceutical experience may be considered
- 2-4 year clinical experience or 2-3 years clinical experience and 1 year pharmacovigilance experience.
- Demonstrated ability to lead project work. Proven success in results-driven process management
- Core knowledge of industry regulations (ICH, FDA, EMEA, MHRA)
- Competent in case processing processes, procedures, convention s
Company
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, and YouTube.
Stock Symbol: ABBV
Stock Exchange: NYSE
Company info
- Website
- http://www.abbvie.com/
- Phone
- 1-800-255-5162
- Location
-
1 North Waukegan Road
North Chicago
Illinois
60064
US
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