About the Role
This role involves analyzing safety information from clinical studies, preparing case reports, and collaborating with cross-functional teams to maintain data integrity and regulatory compliance.
Responsibilities
- Review and assess adverse event data from clinical trials
- Prepare and submit safety case reports in compliance with regulations
- Ensure accurate entry and coding of medical information in safety databases
- Collaborate with team members to resolve data discrepancies
- Support timely processing of expedited safety reports
- Maintain up-to-date knowledge of global regulatory requirements
- Participate in safety data reviews and audits
- Assist in the evaluation of serious adverse events
- Follow standard operating procedures for safety data handling
- Contribute to process improvements in safety reporting workflows
- Interact with internal departments to clarify safety data
- Monitor case processing timelines to meet regulatory deadlines
- Support training initiatives for new team members
- Escalate critical safety findings as defined by protocols
- Maintain confidentiality of sensitive medical data
Nice to Have
- Experience with electronic data capture systems
- Previous work in a clinical trial safety setting
- Familiarity with aggregate reporting requirements
- Training in regulatory compliance
- Exposure to safety management systems
Compensation
Competitive salary and benefits package
Work Arrangement
Hybrid work model with flexibility based on role and location
Team
Part of the global pharmacovigilance team supporting clinical trial safety operations
Why This Role Matters
This position plays a key role in protecting patient safety during clinical development by ensuring accurate and timely evaluation of safety data.
Growth Opportunities
Opportunities exist for professional development and advancement within the safety science function.
Not available for this position
