Senior Clinical Safety Analyst
To see similar active jobs please follow this link: Remote Healthcare jobs
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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
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 guidance’s affecting safety surveillance.
May serve as a representative for CTPS on cross functional projects.
Supports department, division and company's strategic direction by demonstrating the Abbvie “Ways We Work”leadership 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 Bachelor's degree with related health science background. RN or clinical pharmacy experience strongly preferred. o A minimum of 4 years’experience to include at least 2 years of clinical practice experience. In 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 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 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
About the job
Senior Clinical Safety Analyst
To see similar active jobs please follow this link: Remote Healthcare jobs
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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
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 guidance’s affecting safety surveillance.
May serve as a representative for CTPS on cross functional projects.
Supports department, division and company's strategic direction by demonstrating the Abbvie “Ways We Work”leadership 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 Bachelor's degree with related health science background. RN or clinical pharmacy experience strongly preferred. o A minimum of 4 years’experience to include at least 2 years of clinical practice experience. In 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 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 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