Senior, Clinical Safety Analyst

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 companys 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 :

• Bachelors degree with related health science background is required. RN or clinical pharmacy experience strongly preferred. Candidates lacking the appropriate Bachelors 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 Managers 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 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 Companys sole and absolute discretion unless and until paid and may be  modified at the Companys sole and absolute discretion  consistent with applicable 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. 

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Work :

Yes

Employment Type :

Full-time