Senior Clinical Safety Analyst

Purpose:

This position supports the Clinical Trial Patient Safety Organization to achieve its mission of evaluating and
ensuring the quality of clinical trial patient safety data by consistent and accurate delivery of high-quality
relevant and timely data review. Contributes to a culture of process improvement innovation and cross-
functional teamwork aligning with the company vision and strategies.

Responsibilities:

This position is responsible for world-wide surveillance of clinical trial patient safety data and continuous improvement efforts.

Core Job Responsibilities include:

• Provides timely assessment of reported clinical trial data and participates in applicable safety surveillance activities for assigned studies including review and contribution to ad-hoc Safety Reports as needed.
• Provide independent review and analysis of safety-related data from clinical trials for content quality potential study level trend identification and adherence to regulatory guidance and protocols utilizing critical thinking skills.
• Aligns and maintains effective communication channels with key clinical medical study team including CTPS manager regulatory compliance and pharmacovigilance counterparts.
• Maintains constant state of audit readiness for study deliverables.
• Supervises the tracking of safety-related queries to Investigators ensuring appropriate closure.
• In collaboration with medical monitor plans and executes the plan for study safety review.
• Provides safety overview to the clinical team Clinical Research Organizations Investigators and investigator sites as needed.
• Participates in review of study protocols to ensure appropriate safety language.
• Review safety sections of the clinical study reports and other ad-hoc reports which include safety data.
• Creates narratives of serious adverse events and other identified events of interest in accordance with accepted standards.
• Current with knowledge of ICH FDA and EMA regulatory guidances affecting safety surveillance.
• May serve as a representative for CTPS on cross functional projects.
• Supports department division and companys strategic direction by demonstrating the Abbvie Ways We Workleadership behaviors.
• Demonstrates knowledge and expertise through mentoring of new CTPS team members on assigned safety activities.
• Identifies areas of improvements in process and brings forth ideas to leadership

This role can be remote within the US. 

Qualifications :

o Bachelors degree with related health science background. RN or clinical pharmacy experience
strongly preferred.
o A minimum of 4 yearsexperience to include at least 2 years of clinical practice addition
2 year drug safety experience with clinical trial life cycle management Pre-clinical to Phase III
through launch to market is preferred.
o Proficiency in Computers (Windows Word Excel) and in specific databases (e.g. oracle/clinical PIMS
laboratory databases).
o Ability to critically evaluate medical data understanding the clinical course and treatment modalities.
o Demonstrated ability to lead study management activities.
o 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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Yes