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Associate Director, Drug Safety Operations

Job Description

Summary:
The Associate Director, Drug Safety Operations is responsible for operational management and leadership of case processing activities. The role is responsible for managing Case Coordination, Management, and Submission activities within Drug Safety Operations to ensure all ICSR processing comply with regulatory requirements and corporate and departmental procedures. This position requires the ability to influence and lead a diverse team, ensure strong partnership with internal and external partners and with senior management. The incumbent is accountable to compliance with all applicable local and international regulations and company Standard Operating Procedures.

Responsibilities:
* Provides subject matter expertise to Global Safety Operations (GSO) regarding ICSR processing and related regulations, systems, procedures and deliverables
* Oversight and personnel management across GSO Case Management, including goal setting, Manager performance evaluation assessments, and mentoring/career development
* Provide subject matter expertise on safety operations and overall data quality during audits/inspections as required
* Ensure timely submission of expedited safety reports and other external submissions through effective vendor (SMP) management and performance metrics review
* Lead and/or provide functional support for the maintenance and continuous improvement of internal and external case processing (e.g., quality evaluations and metrics)
* Effectively manages interactions with CROs and ensure highest quality of deliverables
* Provide functional support to other GSRM and GSO functions to ensure robust processes conducive to seamless case management activities and deliverables. Provide input as required to business requirements, vendor selection, contract details, vendor oversight /safety management plans (SMP), Pharmacovigilance Agreements (PVAs); review and approve governing documents, such as SOPs, Work Instructions / Training Guides and ensure seamless operational implementation
* Foster strong professional relations with other internal functions, e.g. Data Management, Biometrics, Quality Assurance, Regulatory, and others to optimally collaborate as a team
* Provide oversight and/or functional support for the Drug Safety Database System Owner.
* Other responsibilities as required




About Aerotek:

Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing® winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.



The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 

Job Snapshot

Location US-WA-Bothell
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Biotech, Pharmaceutical
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Company Overview

Aerotek

We know that a company’s success starts with its employees. We also know that an individual’s success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek’s people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has become a leader in recruiting and staffing services by building quality relationships that allow us to place quality people in quality jobs. With more than 230 non-franchised offices, Aerotek’s 6,000 internal employees serve more than 300,000 contract employees and 17,000 clients every year. To learn more, visit Aerotek.com. Learn More

Contact Information

US-WA-Bothell
Barton Minium
4258936050
Snapshot
Aerotek
Company:
US-WA-Bothell
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Biotech, Pharmaceutical
Store Type:

Job Description

Summary:
The Associate Director, Drug Safety Operations is responsible for operational management and leadership of case processing activities. The role is responsible for managing Case Coordination, Management, and Submission activities within Drug Safety Operations to ensure all ICSR processing comply with regulatory requirements and corporate and departmental procedures. This position requires the ability to influence and lead a diverse team, ensure strong partnership with internal and external partners and with senior management. The incumbent is accountable to compliance with all applicable local and international regulations and company Standard Operating Procedures.

Responsibilities:
* Provides subject matter expertise to Global Safety Operations (GSO) regarding ICSR processing and related regulations, systems, procedures and deliverables
* Oversight and personnel management across GSO Case Management, including goal setting, Manager performance evaluation assessments, and mentoring/career development
* Provide subject matter expertise on safety operations and overall data quality during audits/inspections as required
* Ensure timely submission of expedited safety reports and other external submissions through effective vendor (SMP) management and performance metrics review
* Lead and/or provide functional support for the maintenance and continuous improvement of internal and external case processing (e.g., quality evaluations and metrics)
* Effectively manages interactions with CROs and ensure highest quality of deliverables
* Provide functional support to other GSRM and GSO functions to ensure robust processes conducive to seamless case management activities and deliverables. Provide input as required to business requirements, vendor selection, contract details, vendor oversight /safety management plans (SMP), Pharmacovigilance Agreements (PVAs); review and approve governing documents, such as SOPs, Work Instructions / Training Guides and ensure seamless operational implementation
* Foster strong professional relations with other internal functions, e.g. Data Management, Biometrics, Quality Assurance, Regulatory, and others to optimally collaborate as a team
* Provide oversight and/or functional support for the Drug Safety Database System Owner.
* Other responsibilities as required




About Aerotek:

Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing® winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.



The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 
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