Offer summary
Qualifications:
Bachelor’s degree in life sciences, pharmacy, or related field, 3+ years of experience in safety operations within biopharmaceuticals, Strong knowledge of regulatory requirements (FDA, ICH), Experience with early and late-stage clinical trials is desirable, Proficiency in safety databases (e.g., Argus, MedDRA) is a plus.
Key responsabilities:
- Oversee collection and submission of safety information from trials
- Ensure timely processing of adverse events and other notifications
- Collaborate on safety management plans and standard operating procedures
- Manage vendor performance and enforce quality control measures
- Conduct audits to ensure compliance with regulations