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Safety Surveillance

Safety Surveillance

ConfidentialBengaluru / Bangalore
17 days ago
Job description
  • Acting as the owner of the safety sections of the labeling for the evolving Company Core Data Sheet (CCDS) for development products.
  • Maintaining labeling for marketed products and participating as a labeling change request (LCR) reviewer.
  • Preparing relevant sections of Development Safety Update Reports (DSURs), periodic Serious Unexpected Suspected Adverse Reaction (SUSAR) reports, Periodic Safety Update Reports (PSURs), and clinical Risk Management Plans (RMPs).
  • Providing safety input to Product Development Plans (PDP), Trial Outlines, Protocols, Clinical Trial Reports, Investigator s Brochures (IB), integrated safety summaries, abstracts, and planned publications.
  • Proactively communicating safety issues through participation in project / trial groups / teams and conducting Investigator training.
  • Responding to inquiries from Health Authorities (HAs) and Ethics Committees (ECs) regarding safety aspects of protocols and Patient Information (PI) / Informed Consent (ICs).
  • Establishing and ensuring deliverables to / from Data Monitoring Committees (DMCs).
  • Qualifications :
  • Masters in Medicine / MD post-MBBS graduate is preferred.
  • Relevant experience in Signal Management, Aggregate Management, and Individual Case Safety Reports (ICSR).
  • Proficient in Microsoft Office (Outlook, Word, Excel, and PowerPoint).
  • Fluent in written and spoken English.
  • Analytical mindset with a professional authority.
  • Quality-oriented, well-organized, and striving for excellence.
  • Proactive planner to meet agreed deliverables.
  • Strong communicator (verbally and in writing).
  • Curious and constantly looking for improvement opportunities.
  • Team player with a high degree of flexibility and service-mindedness.
  • Cross-cultural awareness.
  • Skills Required

    Outlook, Word, Excel, And Powerpoint

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    Surveillance • Bengaluru / Bangalore

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