A leading biopharmaceutical solutions organization is seeking a Safety Specialist II to manage safety and pharmacovigilance projects in a hybrid work environment. The role involves processing individual case safety reports (ICSRs), maintaining data integrity, and ensuring compliance with global regulations. Ideal candidates will have strong skills in data management and regulatory compliance, enhancing safety reporting practices. This full-time position offers opportunities for career development in a supportive environment.
Qualifications
Ability to manage data and ensure compliance with regulations.
Experience in pharmacovigilance activities and quality reviews.
Familiarity with safety databases and coding systems.
Responsibilities
Enter information into PVG quality and tracking systems.
Assist in the preparation of safety management plans.
Process individual case safety reports according to SOPs.
Coordinate with data management regarding safety data reconciliation.
Skills
Data management
Regulatory compliance
Pharmacovigilance
Quality review
Job description
A leading biopharmaceutical solutions organization is seeking a Safety Specialist II to manage safety and pharmacovigilance projects in a hybrid work environment. The role involves processing individual case safety reports (ICSRs), maintaining data integrity, and ensuring compliance with global regulations. Ideal candidates will have strong skills in data management and regulatory compliance, enhancing safety reporting practices. This full-time position offers opportunities for career development in a supportive environment.