About the Role
The role involves managing and processing adverse event data from clinical trials, ensuring timely and accurate reporting in compliance with global regulations and internal procedures.
Responsibilities
- Process individual case safety reports from various sources including clinical trials and post-marketing channels.
- Enter safety data accurately into the company database following defined timelines.
- Review case documentation for completeness and regulatory compliance.
- Identify and escalate potential safety signals or trends.
- Collaborate with cross-functional teams to resolve data discrepancies.
- Ensure adherence to standard operating procedures and regulatory guidelines.
- Support audit readiness and participate in inspection activities.
- Maintain up-to-date knowledge of global pharmacovigilance regulations.
- Assist in the evaluation of expedited reporting criteria.
- Perform quality checks on safety data entries.
- Contribute to process improvements in safety data management.
- Support training initiatives for new team members.
- Monitor case processing metrics and report performance indicators.
- Escalate critical safety information according to protocols.
- Coordinate with vendors and external partners when necessary.
- Participate in system validation and testing for safety databases.
- Handle follow-up requests for additional medical information.
- Ensure proper documentation of all safety-related activities.
- Work within defined service level agreements for case processing.
- Support periodic safety update report preparations.
- Maintain confidentiality of sensitive medical data.
- Apply medical coding terminology such as MedDRA and WHO Drug.
- Contribute to continuous improvement of safety operations.
- Stay current with evolving industry standards and best practices.
- Assist in the implementation of safety database enhancements.
Compensation
Competitive salary and benefits package offered.
Work Arrangement
Hybrid work model available.
Team
Part of the Global Pharmacovigilance team, collaborating across departments and regions.
Why Join Us
- Opportunity to contribute to patient safety on a global scale.
- Supportive environment that values professional development.
- Work with diverse teams across different regions.
- Engage in meaningful work that impacts public health.
What We Offer
- Comprehensive benefits package including health and wellness programs.
- Flexible work arrangements to support work-life balance.
- Career growth opportunities within pharmacovigilance.
- Access to training and certification programs.
Not available for this position.
