Clinical Safety Analyst

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.

Responsibilities:

• Triages incoming SAE information in order to fulfill timely reporting according to the authority/regulatory requirements.


• Participate in safety surveillance activities for assigned products; and also in area projects/goals. Identify and escalate problems to manager.


• Collecting, analyzing, and triaging Adverse Events including reporting Serious Adverse Events to IND safety including follow-up.


• Timely assessment of adverse event coding for consistency and accuracy of coding.


• Timely, accurate and effective medical review of safety-related CRFs and labs, including communication with Study Designated Physicians.


• Interface with study manager, Clinical Research Organizations, Clinical Research Associates, Data Management, and Pharmacovigilance to assure query resolution.


• Creation of narratives of serious adverse events and other identified adverse events of interest in accordance with accepted standards and with minimal revision required upon review.


• Work closely with study-specific contacts such as; Clinical Safety Manager, clinical research organization, clinical research associates, data management, and pharmacovigilance.


• Responsible for Clinical Safety capture and report, as workload responsibilities are study-related and have a major impact on regulatory compliance and product safety profile.


• Follow scientific arguments and identify safety data needs and adhere to resolution of data completeness regarding all aspects of Clinical Safety that impact product approval, safety signal identification, and patient safety.

Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Qualifications:

• Bachelor's degree with related health science background preferred, RN or clinical pharmacy experience strongly preferred. Candidates lacking the appropriate Bachelor's degree but with previous pharma experience may be additionally considered.


• 2 years clinical experience is required.


• Competent understanding of ICH/FDA regulations and guidelines affecting drug safety issues.


• Sound understanding of product labeling/literature, including safety profile.


• Able to apply clinical knowledge to adverse event data collection and assessment.


• Competent in ability to present adverse event data, orally and in writing.


• Adheres to policies and regulations.


• Must be Computer proficient (Windows, Word, Excel).

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• 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.