Patient Safety Group Manager

Novartis UK

Lead patient safety operational processes
Ensure compliance with global and local procedures
Manage a team of ps associates
Lead Patient Safety operational processes at the Country Organization ensuring compliance with Novartis global and local procedures, national and international regulations/ standards/ guidelines

Job Summary

  • Lead Patient Safety operational processes at the Country Organization ensuring compliance with Novartis global and local procedures, national and international regulations/ standards/ guidelines.
  • Act as qualified delegate of the Local Qualified Person for Pharmacovigilance/ Local PV Responsible Person in Novartis Country Organization, as defined by local regulation and applicable legislation, in terms of ensuring compliance of adverse drug reactions monitoring and submission.
  • Ensure selection, and recruitment of qualified PS team members and their further professional development.

Matching Summary

Lead Patient Safety operational processes at the Country Organization ensuring compliance with Novartis global and local procedures, national and international regulations/ standards/ guidelines.

Skills & Requirements

Must-have

  • Lead Patient Safety operational processes
  • Ensure compliance with global and local procedures
  • Manage a team of PS Associates
  • Qualified delegate of Local Qualified Person for Pharmacovigilance
  • Oversight and compliance in reporting safety information
  • Interact with Health Authorities and functional groups
  • Monitor national pharmacovigilance regulations
  • Set up and implement local procedures
  • Ensure local PS-related RMP commitments
  • Provide scientific expertise for clinical trials
  • Contribute to local program establishment
  • Screen relevant local literature articles
  • Supervision of PS databases
  • Timely preparation and submission of KPI reports
  • Develop and update training materials
  • Support audits and inspections
  • Ensure selection and recruitment of qualified team members
  • Contribute to Pharmacovigilance System Master File

Nice-to-have

  • Knowledge of other languages
  • Business mindset
  • Leadership and people-management skills
  • Excellent communications and negotiation skills
  • Quality and results oriented

Key Requirements

  • Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist), life science degree or equivalent training and experience
  • Fluent in both written and spoken English
  • Fluent in both written and spoken local language
  • 3 years’ experience in pharmacovigilance or equivalent field

Work Rights

Not specified

Tailored Resume

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