Senior Clinical Research Associate
Kerr Dental
Google Cloud Platform
Senior Project Manager, Pharmacovigilance
Clinigen
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Manage daily interaction with Clients, Sponsors and staff to assist in developing and implementing project-specific safety plans, safety documents, SOPs and guidelines
- 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
- 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
- Function in compliance with applicable domestic and international regulations and applicable ICH/GCP guidelines to ensure services are provided in accordance with client and PVG policies, procedures, and contractual agreements
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
- 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 – inclusive company culture
- The Transparency with Leadership – anonymous weekly feedback platform and leadership responsiveness
- The Benefits – broad range of activities, systems, and programs that provide a competitive benefit offering
- EEO – Equal Opportunity Employer committed to equal employment opportunities
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Pharmacovigilancesafety reportingcase processingsafety database configurationcompliance metrics monitoringproject budget managementICH guidelinesGCP guidelinesregulatory inspectionscritical thinking
Soft skills
effective communicationattention to detailorganizationproblem-solvingcollaborationinterpersonal skillsindependencediplomacytime managementmulti-tasking
