Global Risk Management Plan Manager

hace 2 semanas


Barcelona, Barcelona, España Novartis A tiempo completo
Job Summary

The Global Risk Management Plan Manager plays a critical role in ensuring the company's drug, biologics, or medical devices surveillance program is effectively monitored and audited. This includes the intake, evaluation, processing, and follow-up on adverse reports. The successful candidate will participate in the resolution of any legal liability and ensure compliance with government regulations.

Key Responsibilities
  • Monitor and audit the company's drug, biologics, or medical devices surveillance program.
  • Participate in the resolution of any legal liability and ensure compliance with government regulations.
  • Ensure accurate receipt, maintenance, and assessment against product labeling.
  • Report events or reactions as required by regulatory agencies.
  • Provide trending and safety signal detection and assessment.
  • Support all clinical trial activity and post-marketing.
About the Role

The Global Risk Management Plan Manager provides support to the medical safety physicians in the management, coordination, development, reviewing, and tracking of Safety Risk Management Plans. This ensures that documents are of high quality, regulatory compliant, and that logistics and distribution are handled in an appropriate and timely manner.

Key Skills and Qualifications
  • At least 5 years of experience in a pharmaceutical company, preferably in drug safety, clinical research, or regulatory affairs.
  • Proven ability to work with large cross-functional teams in complex projects.
  • Effective communication and teamwork skills.
  • Knowledge of worldwide regulatory requirements for drug registration.
  • Ability to interpret and discuss efficacy and safety data.
  • Solid medical/scientific writing and verbal skills.
  • Fluent in spoken and written English.


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