Full-Time Senior PV Project Manager

Clinigen is seeking a dynamic, consultative, and client-facing Senior PV Project Manager to lead Client programs and manage pharmacovigilance activities.

Key Responsibilities:

• Manage daily client, sponsor, and staff interaction to develop safety plans, documents, SOPs, and guidelines.
• Assist with Safety Management Plan development and database configuration, keeping the project team informed of relevant changes.
• Ensure accurate data entry and maintenance in the safety database.
• Ensure timely maintenance and provision of Pharmacovigilance files to Records Management.
• Manage communications regarding safety issues between team members, clients, and sponsors.
• Participate in training and present conference reports.
• Monitor compliance metrics, project budgets, and service level agreements.

Requirements:

• BS degree (or equivalent experience)
• CRO, pharmaceutical, or biotech experience
• Knowledge of Clinical and/or Post-marketing PVG, FDA/International regulations, ICH/GCP guidelines
• Excellent written and oral communication skills
• Attention to detail and organizational skills
• Critical thinking and problem-solving skills
• Strong collaboration and interpersonal skills
• Proficiency in MS Word, Excel, and PowerPoint
• Self-starter with strong independence
• Ability to manage multiple projects and maintain high quality
• Ability to handle sensitive issues confidentially and professionally

Special Skills:

• Experience with regulatory inspections
• Case processing experience
• Knowledge of ARGUS safety database
• Proficiency in Visio and other Project Management tools

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