Regulatory Intelligence and Analytics Professional
hace 3 semanas
Job Description:
About Us
PrimeVigilance Ltd, a specialized mid-size pharmacovigilance service provider established in 2008, has achieved global organic growth year after year. Our staff based across Europe, North America, and Asia cover services within: Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
We provide first-class support to our pharmaceutical and biotechnology partners, maintaining long-lasting relationships and have become one of the global leaders in our field. We cover all therapy areas, including medical devices.
Our Culture
We invest in our staff by providing an excellent training and development platform. We value employee experience, well-being, and mental health and acknowledge that a healthy work-life balance is crucial for employee satisfaction, leading to a high-quality client service.
Senior Associate, Regulatory Intelligence and Analytics Role
The Senior Associate is responsible for completing regulatory deliverables based on an established regulatory plan. They serve as a liaison between regulatory and other functional areas, including external partners, clients, authorities, and/or consultants, in planning, organizing, and preparing regulatory deliverables following project, corporate, and industry regulatory strategies.
Key Responsibilities:
- Provide intelligence on requirements and contribute to strategy development and setup activities, including Regulatory Management Plans, joint operating procedures, POAs, and core documents.
- Support issue identification and perform regular screening of regulatory legislative requirements updates.
- Maintain the regulatory intelligence database and timely disseminate pertinent changes.
- Provide internal teams with guidance on national requirements.
- Evaluate company procedures, processes, training records, systems, and tools for compliance.
- Promptly identify and escalate risks/potential risks that may jeopardize deliverables.
- Manage awareness of allocated tasks and hours and promptly identify and escalate any Out-of-Scope (OoS) issues.
- Provide administrative support to Business Development activities.
- Foster professional working relationships with internal and external contacts at local and international levels to ensure smooth and efficient service delivery.
- Participate in preparation for audits/inspections and represent the department for assigned projects as required.
- Provide feedback on vendor performance to aid assessment.
Requirements:
To be successful in this role, you should have a degree in Chemistry or Life Sciences, Nursing, or equivalent experience. Previous regulatory experience within the pharmaceutical/CRO industry is necessary.
Compensation Package:
We offer a competitive salary range of $80,000 - $110,000 per annum, depending on your qualifications and experience.
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