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Associate Safety Admin

Pharmaceutical Product Development (PPD)

NC-Morrisville-Morrisville NC 3900 Paramou

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.   

Our detailed, goal-oriented team members manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring tasks. 

Associate Safety Administrator’s provide contracted project coordination and safety support on global and domestic programs with an emphasis on serious and non-serious adverse events, protocol inquiries and physician assessment of diagnostics.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.  

Summarized Purpose:

Provides contracted project coordination and safety support on global and domestic programs with an emphasis on serious and non-serious adverse events, protocol inquiries and physician assessment of diagnostics. In collaboration with Safety Specialists and Medical Monitors, liaises and establishes effective relationships with functional team members to accurately manage all incoming safety documentation.

Essential Functions:   

Coordinates the timely review of protocol inquiries, serious and non-serious adverse events and diagnostics; tracking all necessary data and generating reports for the client, project team and/or external vendors.

Identifies and redacts subject identifiers per local requirements; retraining sites and escalates reoccurrences to PPD Data Privacy.

Compiles adjudication dossiers and creates/submits follow-up to investigative sites.

Manages project specific training in collaboration with the project lead/manager, including the application of training within the learning management system.

Performs data entry into tracking systems and performs system reconciliations to identify issues which may negatively impact project timelines.

Coordinates and facilitates project and/or client meetings, drafts meeting minutes, posts to client portals and distributes to internal and external project teams.

Manages the set-up, maintenance and archival of program files within PPD's electronic filing system.

Liaises with various internal function groups to implement projects, ensuring contractual obligations are met and timelines are achieved.

Answers incoming hotline calls, forwards information received at the Incoming Information Center (IIC) to the designated teams.

Supports any specific activities performed by the local office, which cannot be performed from elsewhere.

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.   

Our detailed, goal-oriented team members manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring tasks. 

Associate Safety Administrator’s provide contracted project coordination and safety support on global and domestic programs with an emphasis on serious and non-serious adverse events, protocol inquiries and physician assessment of diagnostics.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.  

Summarized Purpose:

Provides contracted project coordination and safety support on global and domestic programs with an emphasis on serious and non-serious adverse events, protocol inquiries and physician assessment of diagnostics. In collaboration with Safety Specialists and Medical Monitors, liaises and establishes effective relationships with functional team members to accurately manage all incoming safety documentation.

Essential Functions:   

Coordinates the timely review of protocol inquiries, serious and non-serious adverse events and diagnostics; tracking all necessary data and generating reports for the client, project team and/or external vendors.

Identifies and redacts subject identifiers per local requirements; retraining sites and escalates reoccurrences to PPD Data Privacy.

Compiles adjudication dossiers and creates/submits follow-up to investigative sites.

Manages project specific training in collaboration with the project lead/manager, including the application of training within the learning management system.

Performs data entry into tracking systems and performs system reconciliations to identify issues which may negatively impact project timelines.

Coordinates and facilitates project and/or client meetings, drafts meeting minutes, posts to client portals and distributes to internal and external project teams.

Manages the set-up, maintenance and archival of program files within PPD's electronic filing system.

Liaises with various internal function groups to implement projects, ensuring contractual obligations are met and timelines are achieved.

Answers incoming hotline calls, forwards information received at the Incoming Information Center (IIC) to the designated teams.

Supports any specific activities performed by the local office, which cannot be performed from elsewhere.

Education and Experience:   

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

Technical positions may require a certificate

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities: Self-motivated, positive attitude with effective oral and written communication and interpersonal skillsExcellent computer skills to include MS Office (Word, Excel, PowerPoint, Access)Ability to identify and set priorities and effectively perform a variety of tasks simultaneously with strict deadlinesStrong attention to detail and accuracy with orientation toward careful and meticulous workAbility to work in a team or independently, demonstrating initiative to complete assigned tasks with moderate supervisionAbility to maintain a positive and professional demeanor in challenging circumstancesFlexibility to reprioritize workload to meet changing project timelinesDemonstrated ability to attain and maintain a good working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and PPD/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeoutWorking Environment:  

PPD values the health and well being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May require travel. (Recruiter will provide more details.)

PPD Defining Principles: 

- We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing -We are one PPD - 

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you

Education and Experience:   

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

Technical positions may require a certificate

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities: Self-motivated, positive attitude with effective oral and written communication and interpersonal skillsExcellent computer skills to include MS Office (Word, Excel, PowerPoint, Access)Ability to identify and set priorities and effectively perform a variety of tasks simultaneously with strict deadlinesStrong attention to detail and accuracy with orientation toward careful and meticulous workAbility to work in a team or independently, demonstrating initiative to complete assigned tasks with moderate supervisionAbility to maintain a positive and professional demeanor in challenging circumstancesFlexibility to reprioritize workload to meet changing project timelinesDemonstrated ability to attain and maintain a good working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and PPD/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeoutWorking Environment:  

PPD values the health and well being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May require travel. (Recruiter will provide more details.)

PPD Defining Principles: 

- We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing -We are one PPD - 

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you

Job posted: 2021-01-29

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