Safety Administrator - Bellshill

Safety Administrator - Bellshill (Office based)

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.  

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.   

The Safety Administrator provides project coordination and safety support with a focuson serious and non-serious adverse events, protocol inquiries and physician assessment of diagnostics. In collaboration with Safety Specialists and Medical Monitors you will establish effective relationships with functional team members to accurately manage all incoming safety documentation. 

Essential Functions:    

Coordinates the review of protocol inquiries, serious and non-serious adverse events, diagnostics and Data Safety Monitoring Board data; tracks all necessary data and generates reports for the client, project team and/or external vendors. Interfaces with various internal and external parties to implement projects, prepare Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements based on contractual considerations; reviewing all contractual documents for accuracy and coordinating internal and external approvals. Compiles adjudication dossiers and creates/submits follow-up to investigative sites.  Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and un-blinded minutes/materials to client portals and distributes to internal and external project teams. Manages project specific training and the set-up, maintenance and archival of program files; ensuring PVG remains audit ready. Identifies and redacts subject identifiers per local requirements, retrains sites and escalates re-occurrences to PPD Data Privacy. Performs data entry into internal/external databases, tracking systems and PPD's budget management system; performs system reconciliations to identify issues which may negatively impact project timelines. Oversees expenses and manages translations; ensuring budget parameters are not exceeded. Answers incoming hotline calls, coordinates department functions and performs other duties as assigned. Supports any specific activities performed by the local office, which cannot be performed from elsewhere. Provides training to junior staff.

Safety Administrator - Bellshill (Office based)

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.  

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.   

The Safety Administrator provides project coordination and safety support with a focuson serious and non-serious adverse events, protocol inquiries and physician assessment of diagnostics. In collaboration with Safety Specialists and Medical Monitors you will establish effective relationships with functional team members to accurately manage all incoming safety documentation. 

Essential Functions:    

Coordinates the review of protocol inquiries, serious and non-serious adverse events, diagnostics and Data Safety Monitoring Board data; tracks all necessary data and generates reports for the client, project team and/or external vendors. Interfaces with various internal and external parties to implement projects, prepare Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements based on contractual considerations; reviewing all contractual documents for accuracy and coordinating internal and external approvals. Compiles adjudication dossiers and creates/submits follow-up to investigative sites.  Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and un-blinded minutes/materials to client portals and distributes to internal and external project teams. Manages project specific training and the set-up, maintenance and archival of program files; ensuring PVG remains audit ready. Identifies and redacts subject identifiers per local requirements, retrains sites and escalates re-occurrences to PPD Data Privacy. Performs data entry into internal/external databases, tracking systems and PPD's budget management system; performs system reconciliations to identify issues which may negatively impact project timelines. Oversees expenses and manages translations; ensuring budget parameters are not exceeded. Answers incoming hotline calls, coordinates department functions and performs other duties as assigned. Supports any specific activities performed by the local office, which cannot be performed from elsewhere. Provides training to junior staff.

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 at least 2 years).

Knowledge, Skills and Abilities:  

Self-motivated, positive attitude with effective oral and written communication and interpersonal skills   Excellent 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 deadlines   Strong attention to detail and accuracy with orientation toward careful and meticulous work   Ability to work in a team or independently, demonstrating initiative to complete assigned tasks with moderate supervision   Ability to maintain a positive and professional demeanor in challenging circumstances   Flexibility to reprioritize workload to meet changing project timelines   Demonstrated 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 closeout  

PPD Defining Principles:  

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - 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 at least 2 years).

Knowledge, Skills and Abilities:  

Self-motivated, positive attitude with effective oral and written communication and interpersonal skills   Excellent 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 deadlines   Strong attention to detail and accuracy with orientation toward careful and meticulous work   Ability to work in a team or independently, demonstrating initiative to complete assigned tasks with moderate supervision   Ability to maintain a positive and professional demeanor in challenging circumstances   Flexibility to reprioritize workload to meet changing project timelines   Demonstrated 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 closeout  

PPD Defining Principles:  

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - 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