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Medical Safety Expert

3+ years
Not Disclosed
10 Oct. 9, 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, CPC Certified, 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

Job Summary

Join our Patient Safety & Pharmacovigilance team as a Medical Safety Manager, where you will play a crucial role in ensuring the safety and compliance of our products. You will provide medical reviews and assessments of Individual Case Safety Reports (ICSRs), aggregate reports, and co-author safety documents. Your expertise will support the safety lead in delivering quality outputs while adhering to regulatory requirements and best practices.

About the Role

Major Accountabilities:

  • Medical Review: Conduct thorough medical reviews of ICSRs, including SUSARs and literature cases, and author enhanced Medical Assessment Communication (MAC) documents.
  • Safety Documentation: Support safety leads in authoring medical assessment letters and contribute to various safety-related documents such as PBRERs and DSURs.
  • Data Monitoring: Collaborate with safety leads to monitor product safety profiles through literature reviews and individual case evaluations.
  • Regulatory Support: Assist in preparing for Health Authority queries and contribute to the evaluation of safety for new indications.
  • Cross-Functional Collaboration: Work with global line functions to ensure comprehensive safety management and contribute to cross-functional initiatives.
  • Training & Expertise: Act as a Subject Matter Expert (SME) in medical processes and provide training to Novartis staff.

Minimum Requirements:

  • Educational Background: Bachelor’s in Pharmacy, Nursing, PharmD, PhD, or a medical degree (MBBS/MD).
  • Experience: Minimum of 3 years in the pharmaceutical industry with experience in safety documentation and medical writing.
  • Knowledge: Strong understanding of clinical trial methodology, ICH GCP, GVP guidelines, and medical terminology.
  • Skills: Excellent attention to detail, organizational skills, and strong communication abilities. Proficient in using safety databases and creating documentation.

Why Novartis

At Novartis, we believe in the power of collaboration and innovation to improve patient lives. Join us to be part of a dedicated team driving breakthroughs in healthcare.

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Benefits and Rewards

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Location: Hyderabad, India
Division: Development
Functional Area: Research & Development
Job Type: Full-time
Employment Type: Regular

Accessibility and Inclusion: Novartis is committed to providing reasonable accommodations for individuals with disabilities. Please reach out to diversityandincl.india@novartis.com for assistance.

Join us in creating a diverse and inclusive workplace that reflects the communities we serve!