Description
- Generates integrated compliance data relative to areas of delay (with case processing), trending of aggregate data, root cause analysis and corrective/preventative action planning.
- Liaises with Supplying Organizations and other key external customer groups in support of proactive management of compliance and promotion of corrective action planning activities.
- Assesses timeliness of adverse event reports in accordance with relevant guidelines and internal standards.
- Ensures linkages with Supplying Country Organizations, US Supplying Organizations, EU QP Office and management in proactively facilitating compliance and corrective action planning in support of continuous improvement across adverse event reporting processes.
- Supports the oversight of processes for analytics and reporting of integrated compliance and performance information across adverse event reporting processes and late reports.
- Some overtime made be required (ie putting extra hours in one day and then reducing hours on another day.)
SKILLS:
- European Union (EU) regulation experience
- Proficient with software commonly used to present and analyze data (Word, Powerpoint, and Excel) required
- Two Years of Experience in pharmaceutical industry is required
- Knowledge of global regulatory requirements relative to Pharmacovigilance, regulatory submission and electronic reporting requirements, and other relevant regulations and guidance