Sr Safety Reporting Admin

Pharmaceutical Product Development (PPD)

PH-Taguig City-Taguig City PH 5th Avenue


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. 

Senior Safety Reporting Administrator’s provide administrative support to the Pharmacovigilance department, specifically in relation to submissions, tracking and subsequent filing and archiving of expedited and periodic safety reports.

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 well being of our employees. 

Summarized Purpose:

Provides administrative safety support to the Pharmacovigilance department, specifically in relation to submissions, tracking and subsequent filing and archiving of expedited and periodic safety reports. Leads projects and provides guidance and support to team members in the resolution of problems. May also be involved in updates to procedures and other initiatives related to safety reporting. May mentor or train new central safety reporting admin staff.

Essential Functions:   Responsible for the submission of safety reports to applicable parties, including subsequent scanning, indexing and filing (both electronic and paper), safety tracker completion and quality check, and archiving in accordance with SOP’s and WPD’s. Resolves complex issues with submission packs through discussion with Safety Specialists or Safety Reporting Specialists, with minimal input from Manager.Assists in the receipt and preparation of safety report submissions, including log sheet or electronic system entry, cover letter and third-party email preparation.Provides assistance and direction to team members and liaises with relevant departments on a range of administrative safety reporting tasks, including audit readiness activities, developing training materials, meeting organization, minute taking, filing, photocopying, work distribution, reconciling reports, end of day emails, collation of metrics and updating PPD systems with project allocation.Responsible for extracting and collating reporting information via the Clinical Trial Management System, maintain and update contact lists on PPD systems as required by Safety Specialist or Safety Reporting Specialists. Troubleshoot and provide support to team on arising issues.Supports and leads department and Pharmacovigilance initiatives as relevant.Provides training to Pharmacovigilance department staff on the safety reporting process and procedures and relevant associated PPD systems, with training materials.Assists when required, to provide filing support for multiple projects, including barcoding of safety reports, filing of safety reports, identification and reporting of any problems and inaccuracies to management, as well as responsibility for the file room in terms of cleanliness and organization.Assists with file reviews for completed safety reports, maintains audit notification and file return notification forms and aids with on-site audits if required or requested by PPD or client.Responsible for the coordination of study files and inventories to client, including distribution via external postal services as needed.

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. 

Senior Safety Reporting Administrator’s provide administrative support to the Pharmacovigilance department, specifically in relation to submissions, tracking and subsequent filing and archiving of expedited and periodic safety reports.

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 well being of our employees. 

Summarized Purpose:

Provides administrative safety support to the Pharmacovigilance department, specifically in relation to submissions, tracking and subsequent filing and archiving of expedited and periodic safety reports. Leads projects and provides guidance and support to team members in the resolution of problems. May also be involved in updates to procedures and other initiatives related to safety reporting. May mentor or train new central safety reporting admin staff.

Essential Functions:   Responsible for the submission of safety reports to applicable parties, including subsequent scanning, indexing and filing (both electronic and paper), safety tracker completion and quality check, and archiving in accordance with SOP’s and WPD’s. Resolves complex issues with submission packs through discussion with Safety Specialists or Safety Reporting Specialists, with minimal input from Manager.Assists in the receipt and preparation of safety report submissions, including log sheet or electronic system entry, cover letter and third-party email preparation.Provides assistance and direction to team members and liaises with relevant departments on a range of administrative safety reporting tasks, including audit readiness activities, developing training materials, meeting organization, minute taking, filing, photocopying, work distribution, reconciling reports, end of day emails, collation of metrics and updating PPD systems with project allocation.Responsible for extracting and collating reporting information via the Clinical Trial Management System, maintain and update contact lists on PPD systems as required by Safety Specialist or Safety Reporting Specialists. Troubleshoot and provide support to team on arising issues.Supports and leads department and Pharmacovigilance initiatives as relevant.Provides training to Pharmacovigilance department staff on the safety reporting process and procedures and relevant associated PPD systems, with training materials.Assists when required, to provide filing support for multiple projects, including barcoding of safety reports, filing of safety reports, identification and reporting of any problems and inaccuracies to management, as well as responsibility for the file room in terms of cleanliness and organization.Assists with file reviews for completed safety reports, maintains audit notification and file return notification forms and aids with on-site audits if required or requested by PPD or client.Responsible for the coordination of study files and inventories to client, including distribution via external postal services as needed.

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 4 years).

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: Ability to work effectively in a team as well as independently to attain the wider goals of the teamExcellent critical thinking and problem-solving skillsProactive and uses initiative to solve complex problemsProficiency in Microsoft Office Programs (Word, Excel, PowerPoint, Access) and excellent knowledge of procedural documentsExcellent written and verbal communication skill, including telephone conversations as well as face to face interactionExcellent organization and time management skills, including those of paperwork and files, with proven ability to handle multiple tasks at once and deal effectively with stressExcellent attention to detail and accuracy with orientation towards careful and meticulous workAbility to apply knowledge, skills, and expertise to assist other colleagues in safety reporting activitiesWorking Environment:  

PPD values the health and wellbeing 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 at least 4 years).

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: Ability to work effectively in a team as well as independently to attain the wider goals of the teamExcellent critical thinking and problem-solving skillsProactive and uses initiative to solve complex problemsProficiency in Microsoft Office Programs (Word, Excel, PowerPoint, Access) and excellent knowledge of procedural documentsExcellent written and verbal communication skill, including telephone conversations as well as face to face interactionExcellent organization and time management skills, including those of paperwork and files, with proven ability to handle multiple tasks at once and deal effectively with stressExcellent attention to detail and accuracy with orientation towards careful and meticulous workAbility to apply knowledge, skills, and expertise to assist other colleagues in safety reporting activitiesWorking Environment:  

PPD values the health and wellbeing 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


2020-08-13 00:00:00


Apply to this job