Clinical Trial Compliance Professional
3 dni temu
Are you passionate about delivering high-quality pharmacovigilance services? Do you have a strong background in life sciences and a keen interest in regulatory affairs?
We are Ergomed, a specialized mid-size pharmacovigilance service provider established in 2008. Our team is dedicated to providing exceptional support to our pharmaceutical and biotechnology partners, maintaining long-lasting relationships and becoming one of the global leaders in our field.
Job Description:
You will work independently to manage a variety of case processing services with full accountability. The ideal candidate will have a life science or biomedical background graduate degree and demonstrated experience in case processing.
Key Responsibilities:
- Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, Ergomed procedures, and client-specific requirements and timelines.
- Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations)
- Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.)
- Mentoring and training of new and more junior employees within the department, including procedure optimization and development
Requirements:
- Life science or biomedical background – healthcare-related degree and demonstrated experience in Pharmacovigilance case processing
- Demonstrated case processing experience
- Time and issue management, delegation, organization, and multitasking skills with good attention to detail
- Strong interpersonal and communication skills
- Advanced English skills, both verbal and written, at least C1
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