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Director/Senior Director, PVG- EMEA

Pharmaceutical Product Development (PPD)

United States

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.

We currently have an exciting opportunity for a Director/Senior Director to join our Pharmacovigilance team. This person can be based anywhere within EMEA.

Summarized Purpose:

Oversees daily operations and long term goals for the department and personnel, secures successful compliance and fulfills contracted safety services. Ensures supervision and trains Pharmacovigilance staff. Oversees and mentors other members of their project teams. Interacts with other departments to help meet business objectives. Identifies, develops and implements appropriate policies and procedures to enhance effectiveness and ensures regulatory compliance of the department. Develops and manages resource allocation plans and budgets, and provides forecasts as needed. Oversees, develops, and approves the operational content of departmental proposals and contracts.

Essential Functions: Leads and coordinates the functions of of associate directors and managers for the department. Provides leadership to the department, cultivates a supportive, motivated and collaborative work environment and builds an effective and productive team focused on overall corporate deliverables. Ensures projects are properly resourced, managed and executed and develops verifiable project goals. Manages the overall department budget to include annual and long range forecasting. May communicate with sponsor(s) and obtains direction and feedback on implementing scope of work as well as performance to date. May identify unusual or significant problems encountered for safety processes and proposes strategies for preventing or correcting issues. 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. Fosters client relationships and supervises strategic sell initiatives of the department. Ensures effective training of staff, plans and evaluates training and development programs. Understands department and corporate vision and implements decision making based on core tennets of the vision. Communicates department vision to staff. Manages staff of experienced professionals, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime

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.

We currently have an exciting opportunity for a Director/Senior Director to join our Pharmacovigilance team. This person can be based anywhere within EMEA.

Summarized Purpose:

Oversees daily operations and long term goals for the department and personnel, secures successful compliance and fulfills contracted safety services. Ensures supervision and trains Pharmacovigilance staff. Oversees and mentors other members of their project teams. Interacts with other departments to help meet business objectives. Identifies, develops and implements appropriate policies and procedures to enhance effectiveness and ensures regulatory compliance of the department. Develops and manages resource allocation plans and budgets, and provides forecasts as needed. Oversees, develops, and approves the operational content of departmental proposals and contracts.

Essential Functions: Leads and coordinates the functions of of associate directors and managers for the department. Provides leadership to the department, cultivates a supportive, motivated and collaborative work environment and builds an effective and productive team focused on overall corporate deliverables. Ensures projects are properly resourced, managed and executed and develops verifiable project goals. Manages the overall department budget to include annual and long range forecasting. May communicate with sponsor(s) and obtains direction and feedback on implementing scope of work as well as performance to date. May identify unusual or significant problems encountered for safety processes and proposes strategies for preventing or correcting issues. 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. Fosters client relationships and supervises strategic sell initiatives of the department. Ensures effective training of staff, plans and evaluates training and development programs. Understands department and corporate vision and implements decision making based on core tennets of the vision. Communicates department vision to staff. Manages staff of experienced professionals, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime

Education and Experience: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12 years). 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 tactfully supervise and objectively evaluate divisional staff Excellent interpersonal skills including oral and written communications 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. Has responsibility for managing a function that includes multiple related departments. In some instances 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.

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.)

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

Education and Experience: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12 years). 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 tactfully supervise and objectively evaluate divisional staff Excellent interpersonal skills including oral and written communications 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. Has responsibility for managing a function that includes multiple related departments. In some instances 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.

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.)

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

Job posted: 2021-03-03

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