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Sr. Global Program Safety Team Lead (Immunology)

5-7 years
$204,400 – $379,600/year
10 July 1, 2025
Job Description
Job Type: Full Time Education: Medical degree ,MD PhD, PharmD, or MPH 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

 

Sr. Global Program Safety Team Lead (Immunology) – Novartis, East Hanover, NJ

Job Summary

Novartis is hiring a Senior Global Program Safety Team Lead (GPSTL) in Immunology, based on-site in East Hanover, New Jersey (or Basel, Switzerland). This strategic leadership role oversees global safety risk management for immunology compounds throughout the product lifecycle. The Sr. GPSTL will lead cross-functional safety operations and mentor a team of medical safety professionals while directly influencing benefit-risk evaluations and regulatory submissions.


Key Responsibilities

  • Lead medical safety for assigned immunology products across all development stages.

  • Provide expert clinical safety guidance to the Global Program Team (GPT), Clinical Trial Teams, and other cross-functional partners.

  • Oversee signal detection, risk management, and interpretation of internal and external safety data.

  • Guide the development of Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and other regulatory safety documents.

  • Represent Medical Safety in health authority responses and global regulatory interactions.

  • Mentor and evaluate performance of Medical Safety associates, supporting career development.

  • Ensure compliance with GVP, ICH-GCP, and internal safety SOPs.


Required Skills & Qualifications

  • Medical degree (MD or equivalent) required; PhD, PharmD, or MPH in epidemiology preferred.

  • Board certification or specialty in immunology-related fields desirable.

  • Minimum 5 years postdoctoral clinical experience.

  • 7+ years in drug development, with 5+ years in global safety leadership roles.

  • Strong knowledge of regulatory safety reporting, clinical safety assessments, and NDA/MAA submissions.

  • Proven ability to lead matrixed, multicultural teams.

  • Experience in safety issue resolution, medical writing, and scientific communication.

  • Strong command of global pharmacovigilance frameworks, benefit-risk evaluation, and immunology safety strategy.


Perks & Benefits

  • Salary Range: $204,400 – $379,600/year

  • Additional compensation: sign-on bonus, RSUs, and performance-based awards

  • Comprehensive healthcare (medical, dental, vision)

  • 401(k) eligibility with company contribution

  • Paid time off including vacation, sick leave, and parental leave

  • Access to Novartis learning programs and global mobility options


Company Description

Novartis is a leading global pharmaceutical company dedicated to reimagining medicine. With a focus on immunology, oncology, and rare diseases, Novartis delivers cutting-edge treatments driven by science, patient-centric innovation, and rigorous clinical development.


Work Mode

On-site – East Hanover, NJ (or Basel, Switzerland)
Job Type: Full-time | Employment Type: Regular


Call-to-Action

Are you a passionate leader in drug safety ready to shape the future of immunology treatments? Join Novartis to drive global safety strategy and make a meaningful difference in patient care.
Apply today and advance your safety leadership career.