PPD Manager, Pharmacovigilance in Wilmington, North Carolina
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.
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 Pharmacovigilance Manager you will manage a team of drug safety professionals and oversee the coordination of various safety tasks.
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.
Summarized Purpose: Coordinates contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance. Manages the safety team on respective programs. Works with senior management and develops consistent internal processes and ensures compliance with established processes. Proactively liaises with the Project Manager (as appropriate) and clients and ensures optimal performance and utilization of the safety project team
Essential Functions: * Manages multiple aspects of projects, both local and globally, such as contractual, procedural and regulatory requirements. * Maintains good communications with other functional groups concerning program and company issues. Collaborates with other employees in problem solving and systems improvement. * Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains a basic medical understanding of applicable therapeutic area and disease states. May participate in on-call duties for specific projects and ensures 24-hr coverage for intake of cases from investigative sites. * Provides plans and accurate forecasts for all projects. * Serves as a resource to other departmental managers and leads departmental initiatives. * Prepares and presents proposals. * 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: Bachelor's degree or equivalent and relevant formal academic/vocational qualification to include 3 years of safety experience
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years).
1 year of leadership responsibility
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: * Working knowledge of the global regulatory requirements and the importance of and compliance with procedural documents * Strong knowledge of relevant therapeutic areas as required for processing AEs * General knowledge of pathophysiology and the disease process * Time management and project management skills * Proficient in Microsoft Office products and safety databases * Good command of English and ability to translate information into local language where required * Excellent oral and written communication skills * Strong attention to detail and accuracy * Strong critical thinking, problem solving and decision-making skills 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
Job: *Pharmacovigilance & Drug Safet
Organization: *US BU
Title: Manager, Pharmacovigilance
Location: NC-Wilmington-Wilmington NC HQ
Requisition ID: 206749
PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group