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 have a new Manager role within our Pharmacovigilance Team. The Manager, Pharmacovigilance (PVG) coordinates and manages contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance. Responsible for the management of the Safety Administrators and Safety Specialists on their respective programs.
As a PVG Manager, you ensure that your team has sufficient resources and provides direction on assigned projects and tasks. You will work with other Managers and Senior Management to develop consistent internal processes and ensures compliance with established processes. You will provide plans and accurate forecasts for all projects and ensure timely progress by monitoring study metrics.
The PVG Manager proactively liaises with the Project Manager and clients to ensure optimal performance and utilization of the safety project team. Manages all aspects of multiple projects, both local and globally, ensuring that contractual, procedural and regulatory requirements are met. This may include serving as back-up for project coverage when needed.
You will have responsibility for hiring, training and performance management of project team members including performance reviews and salary administration.
The PVG Manager is responsible for reviewing regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals, as well as maintaining medical understanding of applicable therapeutic area and disease states. You may participate in on-call duties for specific projects to ensure 24-hour coverage for safety reporting.
Ideally, you will have:
- Bachelor’s degree in Nursing, Medical Technology or Pharmacy with 5+ years of clinical experience to include 3+ years of safety experience
- 1 year of management experience or 2 years of mentoring/supervisory experience
- Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills,and abilities to perform the job
Required Knowledge, Skills and Abilities:
- Solid project management skills, including financial management with the ability to manage multiple projects simultaneously
- Ability to coordinate, manage and motivate a team
- Ability to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members, and other internal staff
- Ability to conduct performance management and salary administration and manage employee relations and training/mentoring tasks for direct reports
- Strong knowledge of relevant therapeutic areas as required for processing AEsGeneral understanding of pathophysiology and the disease process
- Ability to work effectively within a team to attain a shared goal
- Advanced computer skills with the ability to work within multiple databases
- Strong critical thinking, problem solving and decision making skills
- Working knowledge of the global regulatory requirements and the importance of and compliance with procedural documents
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.
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Source : CBRE