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Senior Safety Signal Expert

3+ years
Not Disclosed
10 July 25, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Summary

In this role, you will focus on safety signal detection and triage for assigned post-marketing products using both internal and external reporting databases. Your primary responsibilities will include supporting safety leads with signal detection, providing medical evaluations, and ensuring high-quality deliverables in compliance with regulatory standards. You will assist in creating safety documents and responding to Health Authority queries related to automated signal detection, maintaining accuracy and adhering to established procedures.

About the Role

Major Activities:

  • Signal Detection and Triage: Conduct safety signal detection and triage for the assigned product portfolio. Collaborate with safety leads to monitor product safety profiles using internal and external databases.
  • Medical Evaluation: Perform medical evaluations of technical hits in Empirica for assigned products. Assess new cases and cases with significant follow-up information.
  • Review and Reporting: Perform signal triage and provide results to safety leads within set timeframes. Present findings at relevant safety meetings, including Product Safety Teams and Joint Safety Committees.
  • Documentation and Queries: Contribute to MSRB presentations and provide safety input for safety documents and Health Authority queries related to post-marketing signal detection.
  • Database Management: Conduct database searches in external Health Authority databases (FAERS, Vigibase), analyze results, and perform quality checks. Monitor the Eudravigilance database if required.
  • Expertise and Mentoring: Act as a Subject Matter Expert (SME) for post-marketing safety signal detection. Mentor and support junior colleagues in the Safety Signal Expert role.

Minimum Requirements:

  • Medical Degree: MBBS or MD required; specialization preferred.
  • Experience: 3+ years in pharmacovigilance, medical practice, or clinical drug development post-MBBS. Experience with safety documentation and coding using MedDRA and WHO dictionaries.
  • Knowledge: In-depth understanding of ICH GCP, GVP guidelines, medical terminology, and the drug development process.
  • Skills: Strong attention to detail, organizational and project management skills, communication and negotiation abilities, and technical understanding of biomedical and biostatistics concepts.
  • Technical Proficiency: Competent in using safety databases/applications, and skilled in creating spreadsheets, presentations, and templates.
  • Attributes: Ability to work independently, under pressure, and demonstrate innovative leadership. Capable of mentoring and coaching within Patient Safety and cross-functionally.

Why Novartis

Our mission is to reimagine medicine to improve and extend lives. We aim to become the most valued and trusted medicines company globally, driven by our people. Join us to be part of this mission and contribute to meaningful advancements in patient care. Learn more about our vision and people at Novartis Strategy.

Benefits: Discover our comprehensive benefits and rewards in the Novartis Life Handbook.

Commitment to Diversity and Inclusion: We are dedicated to creating an inclusive work environment and building diverse teams that reflect the patients and communities we serve.

Join the Novartis Network: If this role isn’t the perfect fit for you, but you want to stay informed about future opportunities, join our talent community at Novartis Network.

Location

  • Division: Development
  • Business Unit: Innovative Medicines
  • Location: Hyderabad, India
  • Company/Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited
  • Functional Area: Research & Development
  • Job Type: Full-time
  • Employment Type: Regular
  • Shift Work: No