Associate Director, Clinical Trial Patient Safety

North Chicago, IL - USA

Monthly Salary: Not Disclosed

Posted on: 2 hours ago

Vacancies: 1 Vacancy

Job Summary

Purpose :

This position supports the case processing organization to achieve its mission of improving patient lives
globally through industry leading safety and compliance by consistent and accurate delivery of high quality
relevant and timely adverse event information.

Responsibilities :

Directs influences implements and communicates case processing and reporting policy and direction for Global Product Safety.
Evaluates new regulations and guidelines develops plans and processes for implementation
Communicates and coordinates across functional and global boundaries to ensure timely completion of AE cases for regulatory submission.
Identifies evaluates develops and implements Global Products Safety policies processes and system improvements.
Manages department budgets and projects future financial and resource needs
Identifies and anticipates potential department problems impacting the ability to meet regulatory requirements and business goals develops and implements methods of improvement and resolution.
Manages the audit process prepares responses and develops associated improvement plans (e.g. FDA meetings; responses to warning letters)
Works cross-divisionally to influence business processes which impact product safety.
Ensures a positive employee relationship work expectations and employee accountability.
Strategically develops responses to employee relationship trends
In absence of Associate Director is responsible for Associate Director duties including day to day activities.

Qualifications :

Bachelors degree with related health sciences background licensed healthcare professional required. RN BSN BS BS Pharm PharmD or advanced degree preferred. Candidates lacking the appropriate degree but with equivalent previous management or leadership experience may be considered.
Minimum 1 year clinical experience
4 years of pharmacovigilance experience required.
Global exposure preferred
Demonstrated experience in a management capacity required
Significant experience leading cross-functional teams on complex projects required.

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

Employment Type :

Full-time

Purpose :This position supports the case processing organization to achieve its mission of improving patient livesglobally through industry leading safety and compliance by consistent and accurate delivery of high qualityrelevant and timely adverse event information.Responsibilities :Directs influen...

Responsibilities :

Directs influences implements and communicates case processing and reporting policy and direction for Global Product Safety.
Evaluates new regulations and guidelines develops plans and processes for implementation
Communicates and coordinates across functional and global boundaries to ensure timely completion of AE cases for regulatory submission.
Identifies evaluates develops and implements Global Products Safety policies processes and system improvements.
Manages department budgets and projects future financial and resource needs
Identifies and anticipates potential department problems impacting the ability to meet regulatory requirements and business goals develops and implements methods of improvement and resolution.
Manages the audit process prepares responses and develops associated improvement plans (e.g. FDA meetings; responses to warning letters)
Works cross-divisionally to influence business processes which impact product safety.
Ensures a positive employee relationship work expectations and employee accountability.
Strategically develops responses to employee relationship trends
In absence of Associate Director is responsible for Associate Director duties including day to day activities.

Qualifications :

Bachelors degree with related health sciences background licensed healthcare professional required. RN BSN BS BS Pharm PharmD or advanced degree preferred. Candidates lacking the appropriate degree but with equivalent previous management or leadership experience may be considered.
Minimum 1 year clinical experience
4 years of pharmacovigilance experience required.
Global exposure preferred
Demonstrated experience in a management capacity required
Significant experience leading cross-functional teams on complex projects required.

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.

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

Employment Type :

Full-time

Key Skills

Program assessment
FDA Regulations
Manufacturing & Controls
Program Evaluation
budget forecast
Research Experience
Operations Management
Research & Development
Strategic Planning
Contract Management
Leadership Experience
negotiation

Apply Now

About Company

AbbVie

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more

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