At VCLS, we are seeking an experienced and highly organized individual to join our Vigilance team as a Vigilance Project Manager. In this role, you will be responsible for leading and managing cross-functional projects related to pharmacovigilance and drug safety. You will collaborate with internal and external stakeholders to ensure project success and compliance with regulatory requirements.
Responsibilities:
* Lead and manage vigilance projects, including signal detection, risk management, and safety reporting
* Develop and maintain project plans, timelines, and budgets
* Coordinate and collaborate with cross-functional teams to ensure project objectives are met
* Prepare and deliver project updates and reports to stakeholders
* Ensure compliance with regulatory requirements and guidelines
* Identify and mitigate project risks and issues
* Manage internal and external resources to optimize project efficiency
* Contribute to process improvement initiatives within the Vigilance team
Minimum Requirements:
* Bachelor’s degree or equivalent experience.
* Minimum of 4 years direct project management experience at a Contract Research Organization (CRO) or pharmaceutical company and/or 6 years of pharmacovigilance experience.
* Knowledge of global and local Vigilance regulations and legislation, both pre- and post-marketing, drugs and medical devices preferred.
* Strong project management, interpersonal, verbal and written communication skills, both internally and towards clients.
* Ability to identify, document, track and resolve project action items for multiple programs simultaneously.
* Ability to create, review and revise documentation, processes and procedures as they relate to PV activities, to identify issues/problem areas, assess compliance, and communicate findings to the appropriate team(s) and management.
* Experience with industry standard safety database(s).
* Project financial expertise including invoicing, revenue recognition, margin analysis, scope management and resource management.
* Demonstrated supervisory skills preferred.
* Demonstrated independent problem solving and issue resolution track record.
* Excellent interpersonal and client management skills.
* Effective presentation skills.
* Must be flexible and adaptable to quickly changing project priorities.
* Must be able to speak fluent English.
* Ability to travel to VCLS locations, clients, and professional/scientific meetings.
#J-18808-Ljbffr