Safety Specialist - Adjudication

PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you!We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

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.

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.

As a Safety Specialist - Adjudication you will be responsible for completing daily Pharmacovigilance tasks.

Summarized Purpose:

Performs day-to-day Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinates and performs Pharmacovigilance activities such as data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, andthird-partyvendors. May assist in the preparation of departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings.

Essential Functions:

Performs day-to-day PVG activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.

Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintain medical understanding of applicable therapeutic area and disease states.

Reviews cases entered for quality, consistency and accuracy, including review of peer reports.

Prepares and maintains regulatory safety reports.

Assists with routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations. Mentors less experienced staff.

PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you!We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.

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.

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.

As a Safety Specialist - Adjudication you will be responsible for completing daily Pharmacovigilance tasks.

Summarized Purpose:

Performs day-to-day Pharmacovigilance (PVG) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinates and performs Pharmacovigilance activities such as data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, andthird-partyvendors. May assist in the preparation of departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings.

Essential Functions:

Performs day-to-day PVG activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.

Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintain medical understanding of applicable therapeutic area and disease states.

Reviews cases entered for quality, consistency and accuracy, including review of peer reports.

Prepares and maintains regulatory safety reports.

Assists with routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations. Mentors less experienced staff.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).

*Previous adjudication experience is highly preferred

In somecasesan 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:

General understanding of pathophysiology and the disease process

Detailed knowledge of relevant therapeutic areas as required for processing AEs

Strong critical thinking andproblem-solvingskills

Good oral and written communication skills including paraphrasing skills

Good command of English and ability to translate information into local language where required

Computer literate with the ability to work within multiple databases

Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel)

Understanding the importance of and compliance with procedural documents and regulations

Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision

Strong attention to detail

Ability to maintain a positive and professional demeanor in challenging circumstances

Ability to work effectively within a team to attain a shared goal

Management Role:

No management responsibility

Working 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.)  

#LI-PA1

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification.

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).

*Previous adjudication experience is highly preferred

In somecasesan 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:

General understanding of pathophysiology and the disease process

Detailed knowledge of relevant therapeutic areas as required for processing AEs

Strong critical thinking andproblem-solvingskills

Good oral and written communication skills including paraphrasing skills

Good command of English and ability to translate information into local language where required

Computer literate with the ability to work within multiple databases

Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel)

Understanding the importance of and compliance with procedural documents and regulations

Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision

Strong attention to detail

Ability to maintain a positive and professional demeanor in challenging circumstances

Ability to work effectively within a team to attain a shared goal

Management Role:

No management responsibility

Working 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.)  

#LI-PA1