Senior, Clinical Safety Analyst

Allergan; North Chicago (IL); On-site; USD 90,000 - 130,000; Full time

Job summary

AbbVie seeks a Senior Clinical Safety Analyst to independently review safety data from clinical trials, ensure regulatory compliance, and triage adverse events. The role collaborates with physicians, CROs, data management, and pharmacovigilance teams to ensure safety signals are identified and managed.

The successful candidate will interpret safety data, contribute to study reports, and support the department's SOPs while maintaining high-quality medical review standards.

Qualifications

• Bachelor's degree in health sciences is required; RN or clinical pharmacy experience preferred.
• Minimum clinical experience with drug safety/pharma experience as specified in ad.
• Proficiency in computer tools and databases used for safety data management.

Responsibilities

• Review safety data from clinical trials for quality and regulatory adherence.
• Triaging adverse events and coordinating with cross-functional teams.
• Supervise safety query tracking and communicate with investigators as needed.
• Assist with Safety Review Plan development and safety overviews for study teams.
• Create narratives for serious adverse events following regulatory standards.

Skills

Computer proficiency (Windows, Word,

Excel proficiency

Medical data evaluation

Adverse event interpretation

Task prioritization capability

Effective communication

Education

Bachelor's degree in health sciences

RN or clinical pharmacy experience preferred

Tools

Oracle/clinical databases

PIMS

Laboratory databases

Job description

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

The Senior Clinical Safety Analyst independently reviews safety-related data from clinical trials for content, quality, adherence to regulatory guidance and protocols by collecting, analyzing, and triaging Adverse Events as this position impacts product approval, safety signal identification, and patient safety.

Responsibilities

• Participates in applicable safety surveillance activities for assigned products; and in planning and completion of Ad-Hoc Safety Reports as needed.
• Timely assessment of adverse event coding for consistency and accuracy of coding and ; accurate and effective medical review of safety-related CRFs and labs, including communication with Study Designated Physicians by interfacing with study manager, Clinical Research Organizations, Clinical Research Associates, Data Management, Pharmacovigilance and others to assure query resolution.
• Supervise tracking of safety -related queries to Investigators and assists in handling safety questions from IRB/IEC.
• Assist with Study Safety Review Plan development and implementation in collaboration with Study Designated Physicians and provides Safety overview to Clinical team members, Clinical Research Organizations, Investigators and investigator sites as needed and review study protocols, IND reports, annual reports, Investigator Brochures, Safety sections of the Clinical Reports, Monitoring Plans, IDMC data and other ad hoc reports which include safety data.
• Create narratives of serious adverse events and other identified events of interest in accordance with accepted standards and with high degree of competency.
• Apply knowledge of ICH, FDA, EMA regulations and guidelines affecting drug and disease state, understanding issues to assigned responsibilities with an in depth understanding of product labeling/literature, including safety profile. Understand, implements and improves department SOPs. Clinical knowledge to apply to adverse event data collection and assessment.
• May serve as a representative for Safety Management on cross-functional projects, but does not assume decision-making responsibilities in the representative role; Contacts may include Clinical Safety Manager and a variety of multidisciplinary representatives (e.g. Regulatory Affairs, Quality Assurance, Compliance).
• Does not initiate strategic decisions, but is responsible for supporting the department, division and company's strategic direction
• Workload responsibilities are primarily study-related and include some safety higher level functioning (e.g. prioritizing workload, training, reconciliation of databases, safety surveillance). Troubleshoots problems. Problem solving involves identification of problems and proper escalation to manager.
• Starts to mentor/teach others with directions from lead mentor or team manager. Assists in mentoring staff by coaching and mentoring designated Safety staff on assigned safety activities.

Qualifications

• Bachelor's degree with related health science background is required. RN or clinical pharmacy experience strongly preferred. Candidates lacking the appropriate Bachelor's degree but with previous pharma experience may be additionally considered.
• Minimum 3 years clinical experience with a minimum of 1 year drug safety/pharma experience (or) 2 years clinical experience with a minimum of 3 years drug safety/pharma experience.
• Proficiency in Computers (Windows, Word, Excel) and in specific databases (e.g., oracle/clinical, PIMS, laboratory databases).
• Ability to critically evaluate medical data.
• Ability in accurately and medically presenting; of case data, both orally and in writing.
• Ability to identify, prioritize and assign tasks to others in Clinical Safety Manager's absence.
• Monitor problems through resolution.
• Analyze and interpret adverse event data as a component of clinical surveillance activity.
• Consistently exercise good judgment within policies and regulations.
• Effective communication skills in delivering study-related information.

Additional Information

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified in thefuture.

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

• This job is eligible toparticipate in our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremains in the Company'ssole and absolute discretion unless and until paid andmay bemodified at the Company’s sole and absolute discretion, consistent withapplicable law.

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