Compliance Specialist - Pharmacovigilance and Medical Communications - Home Based

Submission for the position: Compliance Specialist - Pharmacovigilance and Medical Communications - Home Based - (Job Number: 182532)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 colleagues in quality strive for excellence in every task, at every moment. We are game changers seeking improvements to processes and more efficient ways of working or adapting to changing financial and industry environments.

As a Compliance Specialist you will execute quality and compliance processes for the Pharmacovigilance/Medial Communications departments.  

Summarized Purpose:

Executes quality and compliance processes across the organization. Facilitates the tracking and reporting of quality and compliance activities. Maintains tools and materials and provides expertise to advance the vision of the department.

Essential Functions: Provides support of client audits for Pharmacovigilance and Medical Communications teams Hosts client audits in PPD offices Tracks client audits and findings, and maintains relevant audit documentation; Supports QA review of SOPs; Quality Event reviews; Quality Agreements; Metrics and Trending Researches issues, tracks metrics, and maintains reports and documentation related to quality and compliance activities. Administers quality and compliance processes and ensures appropriate execution and completion. Contributes to projects and process/quality improvement initiatives. Communicates with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g., client audits, CAPA and/or procedural documents).

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.

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 colleagues in quality strive for excellence in every task, at every moment. We are game changers seeking improvements to processes and more efficient ways of working or adapting to changing financial and industry environments.

As a Compliance Specialist you will execute quality and compliance processes for the Pharmacovigilance/Medial Communications departments.  

Summarized Purpose:

Executes quality and compliance processes across the organization. Facilitates the tracking and reporting of quality and compliance activities. Maintains tools and materials and provides expertise to advance the vision of the department.

Essential Functions: Provides support of client audits for Pharmacovigilance and Medical Communications teams Hosts client audits in PPD offices Tracks client audits and findings, and maintains relevant audit documentation; Supports QA review of SOPs; Quality Event reviews; Quality Agreements; Metrics and Trending Researches issues, tracks metrics, and maintains reports and documentation related to quality and compliance activities. Administers quality and compliance processes and ensures appropriate execution and completion. Contributes to projects and process/quality improvement initiatives. Communicates with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g., client audits, CAPA and/or procedural documents).

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.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 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: Excellent oral andwritten communication skills Solid organizational and time-management skills Firm knowledge of the clinical trial process Thorough knowledge and understanding of ICH GCP and other relevant regulations and guidelines Effective problem solving skills Strongattention to detail Ability to work independently as required Strong computer skills; ability to learn and become proficient with appropriate software Ability to multitask and prioritize competing demands/work load Demonstrated flexibility and adaptability

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.)

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:

Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 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: Excellent oral andwritten communication skills Solid organizational and time-management skills Firm knowledge of the clinical trial process Thorough knowledge and understanding of ICH GCP and other relevant regulations and guidelines Effective problem solving skills Strongattention to detail Ability to work independently as required Strong computer skills; ability to learn and become proficient with appropriate software Ability to multitask and prioritize competing demands/work load Demonstrated flexibility and adaptability

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.)

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. Submission for the position: Compliance Specialist - Pharmacovigilance and Medical Communications - Home Based - (Job Number: 182532)