Senior Medical Safety Analyst ( Remote Opportunity )

Full job description

Company Description

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 Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

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This position supports the case processing 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 information.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• 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.

Qualifications

• 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, conventions

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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