Medical Safety Lead

12+ years

Not Disclosed

Hyderabad

10 Jan. 15, 2025

Job Description

Job Type: Full Time Education: MBBS/MD 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

Medical Safety Lead

Job ID: REQ-10024548
Location: Hyderabad, India
Posted on: January 12, 2025
Employment Type: Full-time, Regular

Role Summary:

As a Medical Safety Lead, you will work closely with the Global Program Safety Lead (GPSL) to ensure optimal patient safety for assigned compounds. This role involves comprehensive safety evaluation, signal detection, and collaboration across multiple departments to ensure robust safety practices throughout the product lifecycle.

Major Accountabilities:

Monitor clinical safety for projects/products through activities such as literature review, individual case evaluations, and signal detection.
Conduct medical assessments, including follow-ups, evaluations of product quality defects, and preparation of periodic reports for ethics committees.
Identify and evaluate safety signals, performing monitoring and analysis to ensure patient safety.
Provide expert evaluation of adverse event reports and their clinical context, assessing implications for Novartis products.
Contribute to regulatory responses, health authority inquiries, and legal queries related to safety issues.
Prepare and present safety data for Health Authority review boards and other regulatory needs.
Collaborate with cross-functional teams including Clinical Development, Regulatory Affairs, Medical Affairs, and Epidemiology on safety tasks.
Provide safety inputs for clinical and regulatory deliverables, such as study protocols, safety assessments, and investigator brochures.
Support licensing activities, regulatory inspections, and project/product recalls as necessary.

Minimum Requirements:

Education: Medical Degree (MBBS or MD); specialization preferred.
Experience:
- At least 12 years in drug development within a major pharmaceutical company.
- Minimum of 6 years in patient safety at an operational or medical position.
- Strong expertise in drug development, clinical trial methodology, regulatory requirements, and scientific writing.
Skills:
- Proven ability to analyze, interpret, and present safety data.
- Experience in preparing clinical safety assessments and regulatory reports.
- Competence in issue management related to safety.

Why Novartis?

Novartis is committed to reimagining medicine, improving lives, and creating breakthroughs that impact patients and their families. This mission is achieved by fostering a collaborative and innovative environment that empowers individuals to thrive professionally and personally.

What We Offer:

Comprehensive benefits detailed in the Novartis Life Handbook.
An inclusive culture that values diversity and promotes collaboration.
Opportunities to work with passionate professionals dedicated to making a difference in healthcare.

Commitment to Diversity and Inclusion:

Novartis is dedicated to creating a diverse and inclusive work environment.

Accessibility:
For reasonable accommodations due to medical conditions or disabilities, contact diversityandincl.india@novartis.com with the job requisition number and your details.

Join the Novartis Network:

Not the right role? Stay connected by joining the Novartis Talent Network for updates on future opportunities.

Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Location: Hyderabad (Office)
Company/Legal Entity: Novartis Healthcare Private Limited

Ready to create a brighter future together? Apply Now

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Medical Safety Lead

Job Description

Medical Safety Lead

Role Summary:

Major Accountabilities:

Minimum Requirements:

Why Novartis?

Commitment to Diversity and Inclusion:

Join the Novartis Network:

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