Senior Pharmacovigilance Project Manager - Remote

Overview

Clinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, EU (Belgium, Germany, France), Asia Pacific and South Africa. Clinigen is growing rapidly and is positioned well for an exciting future of continued expansion.

In Short

• Manage daily interaction with Clients, Sponsors and staff to assist in developing and implementing project-specific safety plans.
• Assist with Safety Management Plan development and safety database configuration.
• Ensure that relevant data is entered and maintained in the safety database system.
• Manage communications when safety issues are identified.
• Participate in training sessions and workshops.
• Monitor compliance metrics, project budgets, and service level agreements.

Requirements

• BS Degree (or equivalent work experience).
• Prior experience in a CRO, pharmaceutical, or biotech company.
• Broad working knowledge of Clinical and/or Post-marketing PVG and safety reporting requirements.
• Effective communicator (written and oral).
• Excellent attention to detail and effective organization.
• Demonstrated critical thinking and problem-solving skills.
• Ability to manage multiple tasks with deadlines.
• Proven effective collaboration with other functional areas.
• Excellent interpersonal skills.
• Computer literacy in MS Word, Excel, and PowerPoint.

Benefits

• Diverse opportunities for engagement and involvement.
• Anonymous feedback with leadership through an employee engagement platform.
• Broad range of activities and programs that provide competitive benefits.