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.

Ensures team has sufficient resources and provides direction on assigned projects and tasks. Works with other Managers and senior management to develop 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 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.

Responsible for hiring, training and performance management of project team members including performance reviews and salary administration.

Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.

Maintains medical understanding of applicable therapeutic area and disease states. May participate in on-call duties for specific projects to ensure 24-hour coverage for safety reporting.

Minimum Required Education and Experience: Bachelor’s degree in Nursing, Medical Technology or Pharmacy with 5+ years of clinical experience to include 3+ years of safety experience1 year of management experience or 2 years of mentoring/supervisory experienceOr 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 simultaneouslyAbility to coordinate, manage and motivate a teamAbility to effectively delegate tasks and ensure successful completionAbility to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members, and other internal staffAbility to conduct performance management and salary administration and manage employee relations and training/mentoring tasks for direct reportsStrong knowledge of relevant therapeutic areas as required for processing AEsGeneral understanding of pathophysiology and the disease processAbility to maintain a positive and professional demeanor in challenging circumstancesAbility to manage and prioritize a variety of tasks and meet strict deadlines without supervisionAbility to work effectively within a team to attain a shared goalAdvanced computer skills with the ability to work within multiple databasesProficient in Microsoft Office products (including Outlook, Word, and Excel) and safety databasesGood command of English and ability to translate information into local language where requiredExcellent oral and written communication skills including paraphrasing skillsStrong attention to detail and accuracyStrong critical thinking, problem solving and decision making skillsWorking knowledge of the global regulatory requirements and the importance of and compliance with procedural documentsExcellent ability to evaluate and escalate as appropriate Working Conditions and Environment: Work is performed in an office environment with exposure to electrical office equipmentDaily exposure to high pressure and intense concentrationDaily interactions with clients/associatesLong, varied hours on occasionTravel required occasionally domestic and/or internationalPhysical Requirements: Frequently vertical and /or stationary for 6-8 hours per day.Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.Frequent mobility required.Frequent bending and twisting of upper body and neck.Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.Ability to access and use a variety of computer software developed both in-house and off-the-shelf.Ability to communicate moderately complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.Frequently interacts with others, relates sensitive information to diverse groups.Ability to apply basic principles to solve conceptual issues.Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.Regular and consistent attendance.Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

Additional Information

Requisition ID: 161031
Additional Information

Requisition ID: 161031