Senior Safety Case Expert

3-5 years

Not Disclosed

Hyderabad India

10 Feb. 10, 2025

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 Title: Senior Safety Case Expert
Location: India (Hyderabad, Office)
Job ID: REQ-10037915
Date Posted: Feb 05, 2025
Division: Development
Business Unit: Innovative Medicines
Employment Type: Full-Time, Regular
Shift Work: No

Job Purpose

The Senior Safety Case Expert is responsible for ensuring compliance with case processing and related activities within PS&PV, adhering to business rules, SOPs, and regulatory requirements. The role involves maintaining relevant manuals, overseeing process changes, and leading cross-functional projects within PS&PV. The expert also provides guidance on case processing and ensures quality and consistency in safety data.

Key Responsibilities

Case Processing & Quality Control

Monitor case processing activities and ensure External Service Providers (ESPs) deliver high-quality and compliant outputs.
Evaluate and QC Serious Adverse Event (SAE) and Post-Marketing Adverse Event (PMAE) data to ensure accuracy, consistency, and compliance with regulatory requirements.
Perform Argus data entry and daily quality reviews (QR) for Individual Case Safety Reports (ICSRs).
Train, coach, and mentor team members, including ESPs, on case processing and quality expectations.

Process Improvement & Change Management

Lead and support process changes driven by internal and external factors, including monitoring process-related metrics.
Develop and maintain manuals, training materials, and communication documents for Novartis and ESPs.
Act as a Subject Matter Expert (SME) for PS&PV associates, Country Organizations, and Global Line Functions on regulatory requirements and business processes.
Contribute to the creation and maintenance of guidance documents and safety management plans, such as Vigilance Agreements (VAs).

Audits, Inspections & Compliance

Support audits and inspections as an SME, developing and implementing Corrective and Preventative Actions (CAPA) for addressing safety-related findings.
Assess and respond to case processing queries from Health Authorities within established timelines.
Facilitate collaboration with other PS&PV functions to drive process improvements and ensure compliance.

Collaboration & Support

Work closely with the Data Management team to support reconciliation and locking of clinical databases.
Alert Medical Safety Physicians of potential safety issues and assist in monitoring the safety profile of products.
Ensure that reports are accurately collected and evaluated in collaboration with country safety departments and license partners.

Operational Projects & Database Validation

Lead PS&PV operational projects, supporting complex or critical projects and database validation activities as required.

Qualifications

Training and Education

Graduate, Postgraduate, or Doctorate degree in Life Sciences, Pharmacy, Medical Sciences, or equivalent.

Experience

Minimum 8 years of industry experience, including 3-5 years in drug safety, pharmacovigilance, or closely related areas.
Experience in document writing is desirable.
Previous experience with pharmacovigilance data entry is a plus.
Strong verbal and non-verbal communication skills.
Ability to work proactively with a sense of urgency and commitment to timely task completion.

Skills

Strong negotiation and ability to operate effectively in a global environment and across line functions.
Self-motivated with a proactive work approach.

Additional Information

Why Novartis: At Novartis, we are committed to making a difference in patients' lives. We offer a collaborative environment where smart, passionate people work together to achieve breakthroughs in science and patient care.
Commitment to Diversity & Inclusion: Novartis fosters an inclusive work environment and is dedicated to building a diverse team reflective of the communities we serve.

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