Vigilance Project Manager

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
  

• Bachelor’s degree or equivalent experience.

• Minimum of 4 year 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 identity, 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 communicates 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.