About the Role
The role involves managing safety data, processing adverse event reports, and supporting compliance with global regulatory requirements for drug safety.
Responsibilities
- Collect, process, and evaluate adverse event reports from clinical trials and post-marketing sources
- Ensure timely and accurate entry of safety data into pharmacovigilance databases
- Assist in the preparation of safety reports for regulatory submissions
- Monitor compliance with standard operating procedures and regulatory timelines
- Perform case processing and narrative writing for serious adverse events
- Collaborate with cross-functional teams to resolve safety data discrepancies
- Support signal detection and risk management activities
- Review medical literature for potential safety signals
- Maintain up-to-date knowledge of global regulatory requirements in pharmacovigilance
- Participate in audits and inspections related to safety data handling
- Escalate critical safety information according to defined protocols
- Contribute to the development and maintenance of safety standard operating procedures
- Provide support during safety-related emergencies or urgent requests
- Verify source documentation for accuracy in safety case reporting
- Assist in training activities related to safety processes
- Work within validated systems to ensure data integrity
- Track and report on key performance indicators for safety operations
- Coordinate with vendors and partners on safety data exchange
- Ensure proper archiving and retrieval of safety records
- Support periodic safety update report (PSUR) compilation
- Identify and report potential process improvements in safety operations
- Maintain confidentiality and data privacy in handling medical information
- Follow company policies for adverse event reporting across regions
- Participate in team meetings and contribute to project planning
- Adhere to quality standards in all safety documentation and reporting
Compensation
Competitive salary and benefits package commensurate with experience
Work Arrangement
Hybrid work model with a combination of remote and office-based work
Team
Part of a global pharmacovigilance team supporting clinical development and regulatory compliance
Why Join Us
- Opportunity to contribute to patient safety in global clinical programs
- Work in a collaborative environment focused on innovation and compliance
- Professional growth through exposure to diverse therapeutic areas and safety projects
Our Commitment to Diversity & Inclusion
- We foster an inclusive workplace that values diverse perspectives
- Equal opportunity employer committed to equity in hiring and development
Not available for this position
