PPD Senior Manager, Pharmacovigilance in Wilmington, North Carolina
Manages contracted safety responsibilities for one or more programs, including staffing, training, and procedural compliance. Manages the safety team on their respective programs. Ensures team has sufficient resources and provides direction on assigned projects and tasks. Works with other managers and senior management, and develops consistent internal processes and ensures compliance with established processes. Provides plans and accurate forecasts for all projects and ensures timely progress by monitoring study metrics. Proactively liaises with the Project Manager (as appropriate) and clients and ensures optimal performance and utilization of the safety project team. Works on more complex global studies.
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. * Serves as a resource and mentor to other departmental managers. 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.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years). 2 years of management responsibilityIn 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
- Solid project management skills, including financial management
- Ability to manage and prioritize a variety of tasks
- 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
Manager role with significantly larger management scope (e.g. global or regional responsibilities or multiple departments) OR mastery of manager skills and responsibilities as demonstrated by consistent, multi-year successful performance. In some instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees.
/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.)
Job: *Pharmacovigilance & Drug Safet
Organization: *US BU
Title: Senior Manager, Pharmacovigilance
Location: NC-Wilmington-Wilmington NC HQ
Requisition ID: 207750
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