💼 Job Title: Coding and Dictionary Management Lead
Job ID: REQ-10062089
Date Posted: September 24, 2025
Location: Hyderabad, India
Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Job Type: Full-Time (Regular)
Shift Work: No
🧭 Summary
The Coding and Dictionary Management Lead provides effective leadership and guidance to team members, fostering a positive, collaborative work environment. The role supports the Patient Safety & Pharmacovigilance (PS&PV) mission by ensuring proactive, accurate safety signal detection, MedDRA query management, and regulatory compliance.
You will guide safety physicians on MedDRA grouping terms, case retrieval strategies, and query definitions to ensure consistent identification of potential safety concerns across clinical and marketed products. You may also deputize for the Global Head of Safety Signal Detection during MSRB meetings, audits, or inspections.
⚙️ Key Responsibilities
🔹 Leadership & Governance
Lead the Cross-Functional MedDRA Team (CMT) responsible for developing and updating Novartis MedDRA Queries (NMQs) across therapeutic areas.
Ensure uniform and rational risk definitions during both development and post-marketing phases.
Participate in Safety Management Teams (SMTs) to evaluate and optimize product Case Retrieval Strategies (CRS).
Review MedDRA query use across products and ensure consistency for similar safety topics.
🔹 Standards & Compliance
Establish best practices for creating and maintaining custom queries, case retrieval strategies, and regulatory dictionary versioning.
Provide guidance on GCP, GVP, and regulatory requirements related to MedDRA, WHO Drug, IMDRF, IDF-J, WHO Drug SK, and CRT.
Support audits and inspections, ensuring compliance across PS&PV and other Novartis divisions.
🔹 Regulatory Dictionary Management
Identify and resolve implementation issues that impact compliance or safety signal quality.
Guide stakeholders on product configuration management, including expediting rules per regulatory requirements.
Liaise with MSSO and UMC for change requests, new term submissions, and SMQ/SDG updates.
🔹 Training & Development
Design and deliver training on:
MedDRA version updates (biannually)
Regulatory dictionary fundamentals
Data extraction & analysis using MedDRA/SMQ/WHO Drug
Custom query creation (SDG MedDRA approach)
Lead Regulatory Dictionary Update Activities (impact assessment, term list updates, deactivated term repointing).
🔹 Strategic & Functional Support
Deputize for Global Head of Safety Signal Detection and MQM at MSRB meetings and during audits.
Stay updated with trends and best practices in controlled terminologies and MedDRA query management.
Support adoption of new tools, technologies, and methodologies to improve efficiency and accuracy.
🎯 Key Performance Indicators (KPIs)
Collaboration & Communication: Effective teamwork across cross-functional groups.
Compliance: Adherence to company policies, SOPs, and regulatory requirements.
Audit Readiness: Positive audit/inspection outcomes with no critical findings.
MedDRA Consistency: Up-to-date, standardized search definitions across programs.
🧠 Ideal Background
🎓 Education
Bachelor’s / Master’s in Pharmacy or Pharm.D.
Expertise in MedDRA (search strategies, coding, hierarchies, grouping definitions such as SMQs).
🌐 Languages
Fluent in spoken and written English.
💼 Experience
8+ years of experience in drug development at a major pharmaceutical company.
4+ years in Patient Safety / Signal Detection (preferred).
Strong knowledge of pharmacovigilance regulations and requirements.
Expertise in MedDRA / WHO Drug coding, custom queries, case retrieval strategies, and SMQ management.
Strong analytical, communication, and attention-to-detail skills.
Familiarity with clinical/safety databases and signal detection tools.
Proven ability to work effectively in cross-functional teams.
🌍 Why Novartis
At Novartis, helping people and their families means combining science with a community of passionate, collaborative people. Together, we create breakthroughs that transform patients’ lives.
🌱 People & Culture: About Novartis
💡 Talent Network: Join Our Network
🎁 Benefits & Rewards: Learn More
🏢 Company Details
Company / Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Site: Hyderabad (Office)
Employment Type: Regular
Shift Work: No
♿ Accessibility & Accommodation
Novartis is committed to diversity and inclusion. If you require reasonable accommodation due to a disability or medical condition, please contact
📧 diversityandincl.india@novartis.com (include job requisition number).
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