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Safety Manager

2 months ago

Bengaluru, India Excelya Full time

Excelya

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service, functional service provider and consulting - allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

To learn more about us, visit www.excelya.com


Position:

The Safety manager is responsible for managing the Team and ensure all process

  • Line Management of Case processing team Safety officer
  • Ensure all processes are deployed and applied by the Safety team for Individual Case Safety Report management activities​
  • Snr Safety project Manager support on Back Office management activites​
  • Safety Team Leader support on Back Office management activites​
  • Safety Officer support on Back Office Management activites​

Education and Experience

  • At least 6 years of previous working experience in Pharmacovigilance
  • At least 3 years of managerial experience in healthcare sector preferably with line management activity
  • Strong understanding of global pharmacovigilance regulations, such as FDA, EMA, MHRA, ICH, and GVP guidelines
  • Proficiency in core pharmacovigilance activities (case management, reconciliation, literature monitoring, etc.)
  • Strategic thinking and problem-solving personality
  • Excellent communication and presentation skills
  • Efficiency in allocating resources, managing workloads and identifying opportunities for process optimization
  • Ability to lead, motivate and inspire a team
  • Self-confidence; self-motivated with high emotional intelligence
  • Multi-tasking with excellent organizational skills
  • Experience in regulatory inspections and internal/external audits
  • Fluency in English