Pharmacovigilance Director

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.  

Pharmacovigilance:

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.

We have a new and exciting opportunity within our Central Safety Reporting Team to join them as a Director. This is to support the on going growth within this successful team.

Your main responsibility as Director will be to provide oversight to this group and will be directly for the Central Safety Reporting Team and other potential work as needed in the future.

You will oversee daily operations and long-term goals for the department and personnel, secure successful compliance and fulfill contracted safety services.

You will oversee and mentor Associate Directors and other members of their project teams and provide support to Physicians.

As Director for this team, you will interact with other departments to help meet business objectives. It will be your responsibility to identify, develop and implement appropriate policies and procedures to enhance effectiveness and ensures regulatory compliance of the department. It is also your responsibility to manageresource allocation plans and budgets, and provide forecasts as needed. Essential Functions:

Leads and coordinates the functions of Associate Directors and managers for the PVG department. Responsible for salary administration, performance management, conflict resolution, recruiting and mentoring for Associate Directors and other direct reports.

Provides leadership to the PVG department, cultivates a supportive, motivated and collaborative work environment and builds an effective and productive team focused on overall corporate deliverables.

Manages the overall department budget to include annual and long range forecasting.

Communicates with sponsor(s) and obtains direction and feedback on implementing scope of work as well as performance to date. I

Assists business development and obtains additional contracts, writes and reviews proposals, makes presentations to potential clients and represents the

department at appropriate professional meetings and conferences.

Ensures effective training of PVG staff, plans and evaluates training and development programs.

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.  

Pharmacovigilance:

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.

We have a new and exciting opportunity within our Central Safety Reporting Team to join them as a Director. This is to support the on going growth within this successful team.

Your main responsibility as Director will be to provide oversight to this group and will be directly for the Central Safety Reporting Team and other potential work as needed in the future.

You will oversee daily operations and long-term goals for the department and personnel, secure successful compliance and fulfill contracted safety services.

You will oversee and mentor Associate Directors and other members of their project teams and provide support to Physicians.

As Director for this team, you will interact with other departments to help meet business objectives. It will be your responsibility to identify, develop and implement appropriate policies and procedures to enhance effectiveness and ensures regulatory compliance of the department. It is also your responsibility to manageresource allocation plans and budgets, and provide forecasts as needed. Essential Functions:

Leads and coordinates the functions of Associate Directors and managers for the PVG department. Responsible for salary administration, performance management, conflict resolution, recruiting and mentoring for Associate Directors and other direct reports.

Provides leadership to the PVG department, cultivates a supportive, motivated and collaborative work environment and builds an effective and productive team focused on overall corporate deliverables.

Manages the overall department budget to include annual and long range forecasting.

Communicates with sponsor(s) and obtains direction and feedback on implementing scope of work as well as performance to date. I

Assists business development and obtains additional contracts, writes and reviews proposals, makes presentations to potential clients and represents the

department at appropriate professional meetings and conferences.

Ensures effective training of PVG staff, plans and evaluates training and development programs. Education and Experience:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12 years) or equivalent and relevant combination of education, training, and experience. 5 years of management responsibility Strong leadership skills

Knowledge, Skills and Abilities:

Thorough understanding of client business practices and an in depth understanding of PPD operational/financial practices and functional areas

Expert knowledge in global regulatory requirements for adverse event reporting, ICH safety guidelines, GCP etc

Knowledgeable of safety database management

Strong influencing and negotiation skills

Ability to liaise with business development and present safety services to clients

Strong analytical skills with ability to analyze and evaluate processes and procedures

Ability to handle multiple issues on multiple projects simultaneously

Ability to maintain a high degree of independence with respect to decision making and problem solving

Management Role:

Directs through lower management levels.

You will have responsibility for managing a function that includes multiple related departments. In some instances you may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees.

May manage employees across multiple regions. Working Conditions and Environment:

Daily exposure to high pressure and intense concentration

Daily interactions with clients/associates

Long, varied hours on occasion

Travel required occasionally domestic and/or international

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

- 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.

Closing date for applications- Friday 26th June

Education and Experience:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12 years) or equivalent and relevant combination of education, training, and experience. 5 years of management responsibility Strong leadership skills

Knowledge, Skills and Abilities:

Thorough understanding of client business practices and an in depth understanding of PPD operational/financial practices and functional areas

Expert knowledge in global regulatory requirements for adverse event reporting, ICH safety guidelines, GCP etc

Knowledgeable of safety database management

Strong influencing and negotiation skills

Ability to liaise with business development and present safety services to clients

Strong analytical skills with ability to analyze and evaluate processes and procedures

Ability to handle multiple issues on multiple projects simultaneously

Ability to maintain a high degree of independence with respect to decision making and problem solving

Management Role:

Directs through lower management levels.

You will have responsibility for managing a function that includes multiple related departments. In some instances you may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees.

May manage employees across multiple regions. Working Conditions and Environment:

Daily exposure to high pressure and intense concentration

Daily interactions with clients/associates

Long, varied hours on occasion

Travel required occasionally domestic and/or international

At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.

- 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.

Closing date for applications- Friday 26th June