Full-Time Senior Pharmacovigilance Manager (PV Systems)
Ergomed is hiring a remote Full-Time Senior Pharmacovigilance Manager (PV Systems). The career level for this job opening is Senior Manager and is accepting Prague, Czech Republic based applicants remotely. Read complete job description before applying.
Ergomed
Job Title
Posted
Career Level
Career Level
Locations Accepted
Share
Job Details
Role Summary: The PV Manager leads safety database oversight to ensure data quality, regulatory compliance, system optimization and team development.
Key Responsibilities:
- Develop and deliver standard and custom safety reports to meet regulatory and internal needs.
- Oversee database design, setup and configuration in collaboration with IT, Safety and Project teams.
- Lead validation of computerized PV systems and ensure compliance with GxP and 21 CFR Part 11.
- Manage data migration between legacy and modern safety databases ensuring integrity and traceability.
- Develop and deliver training programs and mentor junior PV staff.
- Act as SME for safety system configuration and drive cumulative data quality reviews and data integrity initiatives.
- Create and refine SOPs, implement continuous improvement and support audits/inspections.
- Collaborate with cross-functional teams and support business development activities related to safety systems.
Qualifications & Skills: Degree in Life Science, Project Management, Business Analysis or IT-related field; demonstrated experience with pharmacovigilance systems (on-premise or cloud); strong organizational, communication, presentation, leadership and coaching skills.