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Medical Safety Lead

12+ 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

Summary

In close collaboration with the Global Program Safety Lead (GPSL), this role provides essential safety evaluation expertise and drives medical innovation to enhance patient lives and contribute to Novartis's overall success. As a member of the Medical Safety organization, you will prioritize patient safety for assigned compounds and share responsibility for the integration, analysis, and evaluation of both internal and external safety information throughout the product lifecycle.

About the Role

Note: This position is open in Hyderabad, India, and Barcelona, Spain.

Job Description

Major Accountabilities:

  • Monitor the clinical safety of projects/products through activities such as literature reviews, individual case evaluations, and signal detection; respond appropriately to safety-related inquiries.
  • Conduct medical assessments for cases as needed, including collecting follow-up information, evaluating product quality defects related to adverse events, reviewing single case listings, and preparing notifications for investigators and ethics committees.
  • Identify safety signals from solicited or unsolicited individual cases.
  • Perform signal detection, monitoring, and evaluation of all safety signals.
  • Provide input for responses to inquiries from regulatory authorities and healthcare professionals regarding safety issues.
  • Prepare safety data for review by health authorities.
  • Contribute to responses for legal inquiries and requests from country organizations involving safety concerns.
  • Offer expert evaluations on the clinical context of adverse event reports, assessing medical conditions and their implications for Novartis products.
  • Collaborate effectively on clinical safety tasks with colleagues from Clinical Development, Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology, and other related departments.
  • Provide safety inputs for clinical and regulatory deliverables, including clinical study protocols, clinical study reports, and investigator brochures. Participate in Global Program/Brand Team (GPT/GBT), Global Clinical Team (GCT), and Clinical Trial Team (CTT) meetings as needed, and support licensing activities, regulatory inspections, and project/product recall activities.

Minimum Requirements

  • Bachelor of Science in Pharmacy, Nursing, PharmD, PhD in a relevant field, or Medical Degree (MBBS or MD) required; specialization preferred. A medical degree is essential for associates performing medical reviews of single case reports as business needs arise.
  • At least 12 years of experience in drug development within a major pharmaceutical company, including 6 years in patient safety in an operational or medical role (or equivalent experience).
  • Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics, and writing publications.
  • Proven ability to analyze, interpret, discuss, and present safety information effectively, both in writing and orally.
  • Experience in preparing or contributing to clinical safety assessments and regulatory reports involving safety information, and in managing safety issues.

Join Our Novartis Network

If this role doesn’t align with your experience or career goals but you want to stay connected, join the Novartis Network here.

Why Novartis

Helping people with diseases and their families requires more than innovative science; it demands a community of dedicated individuals like you. By collaborating and supporting one another, we can achieve breakthroughs that change patients' lives. Ready to create a brighter future together? Learn more about our strategy and culture here.

Benefits and Rewards

Discover how we support your personal and professional growth in our benefits handbook.

Division

  • Development

Business Unit

  • Innovative Medicines

Location

  • Hyderabad, India (Office)

Company / Legal Entity

  • IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

  • Research & Development

Job Type

  • Full Time

Employment Type

  • Regular

Shift Work

  • No

Accessibility and Accommodation

Novartis is committed to providing reasonable accommodations for individuals with disabilities. If you require assistance due to a medical condition or disability during the recruitment process or to perform essential job functions, please email us at diversityandincl.india@novartis.com, including the job requisition number in your message.

Novartis is dedicated to creating an inclusive work environment and building diverse teams that reflect the patients and communities we serve.