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Senior Medical Safety Lead

Novartis
Novartis
6+ years
Not Disclosed
Hyderabad
1 May 6, 2026
Job Description
Job Type: Full Time Education: Bachelor of Science in Pharmacy / Bachelor of Science in Nursing / PharmD / PhD in relevant field or Medical Degree (MBBS or MD) required. Skills: Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Scien

Senior Medical Safety Lead

Location: Hyderabad (Office)
Job Type: Full-Time
Experience Required: Minimum 6+ Years in Drug Development & Patient Safety
Application Deadline: May 10, 2026
Industry: Pharmaceutical / Pharmacovigilance / Clinical Research


Job Overview

We are seeking an experienced and highly analytical Senior Medical Safety Lead to oversee drug safety surveillance, pharmacovigilance operations, risk management activities, and clinical safety assessments across the product lifecycle. The selected candidate will play a critical role in monitoring adverse events, evaluating safety signals, supporting clinical development programs, and ensuring compliance with global regulatory standards.

This role is ideal for professionals with strong expertise in patient safety, clinical trials, pharmacovigilance, and medical risk assessment within pharmaceutical or healthcare organizations.


Key Responsibilities

Clinical Safety & Pharmacovigilance

  • Monitor the clinical safety profile of assigned products and projects across:
    • Clinical trials
    • Post-marketing surveillance programs
    • Drug development activities
  • Conduct:
    • Literature reviews
    • Safety evaluations
    • Signal detection activities
    • Aggregate data analysis
  • Assess adverse event reports and determine:
    • Relatedness to product
    • Medical significance
    • Risk impact

Safety Signal Detection & Risk Management

  • Identify and evaluate safety signals using:
    • Single case reports
    • Aggregate safety data
    • Pharmacovigilance tools
  • Support development and maintenance of:
    • Safety Profiling Plans (SPP)
    • Risk Management Plans (RMP)
    • Core Data Sheets (CDS)
  • Track safety commitments, effectiveness measures, and ongoing risk mitigation activities.

Medical Review & Regulatory Support

  • Perform medical assessments for individual case safety reports when required.
  • Review:
    • Clinical safety data
    • Line listings
    • Medical quality defects
    • Investigator notifications
  • Support preparation of:
    • Clinical safety assessments
    • Regulatory submissions
    • Clinical overviews
    • Ethics committee documentation
  • Provide responses to:
    • Regulatory authority inquiries
    • Healthcare professional safety questions
    • Legal and compliance-related safety requests

Cross-Functional Collaboration

  • Collaborate with:
    • Clinical Development Teams
    • Regulatory Affairs
    • Medical Affairs
    • Safety Data Management
    • Epidemiology Teams
    • Statistics & Medical Information Departments
  • Provide safety inputs for:
    • Clinical study protocols
    • Clinical study reports
    • Investigator brochures
    • Global program deliverables

Safety Oversight & Strategic Support

  • Support safety monitoring activities across product development lifecycles.
  • Provide expert medical evaluation regarding:
    • Adverse events
    • Patient safety concerns
    • Clinical risk assessments
  • May function as a Global Patient Safety Lead (GPSL) for assigned products where applicable.

Required Qualifications

Educational Qualifications

Required Education:
Candidates must possess one of the following qualifications:

  • Bachelor of Science in Pharmacy (B.Pharm)
  • Bachelor of Science in Nursing (BSc Nursing)
  • PharmD
  • MBBS
  • MD
  • PhD in relevant healthcare or life sciences field

Preferred Qualifications

  • Medical Degree (MBBS or MD) preferred
  • Specialization in:
    • Pharmacology
    • Clinical Research
    • Internal Medicine
    • Drug Safety
    • Pharmacovigilance
  • Certifications in:
    • Pharmacovigilance
    • Clinical Safety
    • Drug Development
    • Regulatory Affairs
    • Clinical Research

Note: Medical degree holders are preferred for roles involving medical review of single case safety reports.