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.
To support our growth, we are seeking a dynamic, consultative and client facing Senior PV Project Manager responsible for serving as the Lead on Client programs and for supporting the management of all pharmacovigilance activities under the direction of the Associate Director of Client Services.
As our new Senior PV Project Manager, you will function in compliance with applicable domestic and international regulations and applicable ICH/GCP guidelines to ensure services are provided in accordance with the client and PVG policies, procedures, and contractual agreements.
Please Note: Candidates without Pharmacovigilance experience need not apply at this time.
Key Responsibilities:
- 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.
Requirements
- 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 PowerPoint.
- 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.
Special Skills:
- 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.
Benefits
While at Clinigen, you’ll enjoy:
The Culture. Thanks to our diverse opportunities for engagement and involvement, every colleague’s Clinigen experience can be a bit different, and we’re proud of that. We work hard to ensure our company culture is inclusive to people from all backgrounds and social styles.
The Transparency with Leadership. All colleagues can share anonymous feedback with leadership on a weekly basis through our employee engagement platform. We use this feedback to inform our actions and decisions. We’ve been able to take steps to continuously improve how we do things at Clinigen.
The Benefits. We take pride in having a broad range of activities, systems, and programs that provide a competitive benefit offering and build a culture of celebrating success.
EEO. 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.
