Senior Project Manager; Pharmacovigilance

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.

Please Note: Candidates without Pharmacovigilance experience need not apply at this time.

• Manage daily interaction with Clients, Sponsors and staff to assist in developing and implementing project-specific safety plans, safety documents, SOPs and guidelines to reflect specific work processes
• Assist with Safety Management Plan development and safety database configuration and ensure project team is up to date on all relevant changes
• Ensure that relevant data is entered and maintained in the safety database system in collaboration with the Medical/Safety business unit
• Ensure Pharmacovigilance files for assigned projects are properly maintained and/or provided to Records Management in a timely manner
• Manage communications between appropriate team members, Clients, and Sponsors when safety issues are identified
• Participate in training sessions and workshops, including presenting reports from any conferences attended, as agreed
• Monitor compliance metrics, project budgets, and service level agreements for assigned projects to ensure regulations and timelines are being met and activities performed are within the approved budget

• BS Degree (or equivalent work experience)
• Prior experience working in a contract research organization (CRO), pharmaceutical and/or biotech company
• Broad working knowledge of Clinical and/or Post-marketing PVG and safety reporting requirements under the FDA/International regulations, ICH/GCP guidelines and other relevant requirements
• Effective communicator (written and oral); concise, accurate and business appropriate
• 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 Power Point
• Self-starter, able to work with a high degree of independence
• Ability to manage multiple projects simultaneously while maintaining a high level of quality
• Ability to diplomatically address sensitive issues confidentially and professionally

• Prior experience with regulatory inspections
• Previous experience of case processing
• Working knowledge of the ARGUS safety database
• Computer literacy in Visio and other Project Management tools

Clinigen is an Equal Opportunity Employer and is committed to providing equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law.