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Regulatory Safety Lead (Md)

Propharma
Propharma
15+ years
Not Disclosed
United States
1 May 7, 2026
Job Description
Job Type: Contract Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill

Regulatory Safety Lead (MD) – Remote Pharmacovigilance Leadership Job in the United States

Company: ProPharma
Job Title: Regulatory Safety Lead (MD)
Location: United States (Remote)
Job Type: Full-Time Contract
Contract Duration: 6+ Months
Job ID: JR 9427


About ProPharma

ProPharma is a globally recognized life sciences consulting organization supporting pharmaceutical, biotechnology, and medical device companies across regulatory affairs, pharmacovigilance, clinical research, quality compliance, and medical information services. With over two decades of expertise, ProPharma helps organizations accelerate scientific innovation while maintaining the highest standards of patient safety and regulatory compliance.


Job Overview

ProPharma is seeking an experienced Regulatory Safety Lead (MD) to support strategic pharmacovigilance and global drug safety operations for late-stage development programs and upcoming regulatory submissions.

This senior leadership role will take on responsibilities similar to a Head of Pharmacovigilance and will directly support critical NDA submission activities planned for 2026. The selected candidate will oversee global safety strategy, regulatory authority interactions, pharmacovigilance operations, and risk management initiatives in a highly collaborative remote environment.

This is an excellent opportunity for an accomplished pharmacovigilance physician leader with extensive biotech or pharmaceutical industry experience.


Experience Required

Experience Level

  • Senior-Level / Executive-Level Position
  • Not suitable for freshers

Required Experience

  • Minimum 15+ years of progressive experience in:
    • Pharmacovigilance
    • Global Drug Safety
    • Regulatory Safety
    • Risk Management
    • Safety Surveillance

Mandatory Background

  • Prior experience serving as:
    • Head of Pharmacovigilance
    • Global Drug Safety Lead
    • Senior PV Leadership Role

Experience within large pharmaceutical companies or well-established biotechnology organizations is strongly preferred.


Educational Qualification

Required Qualification

  • MD (Doctor of Medicine) is mandatory

Key Responsibilities

Global Pharmacovigilance Leadership

  • Lead global pharmacovigilance and regulatory safety activities
  • Oversee safety surveillance and signal management processes
  • Guide benefit-risk assessment strategies for clinical and commercial products

Regulatory Authority Management

  • Represent the organization during FDA and global health authority interactions
  • Support regulatory inspections, audits, and safety reviews
  • Manage safety-related communications with international regulatory agencies

NDA/BLA Submission Support

  • Contribute to late-stage clinical development programs
  • Support NDA/BLA submission preparation and execution
  • Ensure pharmacovigilance readiness for commercialization activities

Safety Operations Oversight

  • Supervise:
    • Case management
    • Safety reporting
    • PV compliance
    • Quality systems
    • Risk management activities
  • Ensure global safety processes comply with industry regulations and standards

Process Development & Infrastructure

  • Build and optimize scalable pharmacovigilance systems and infrastructure
  • Establish fit-for-purpose PV operational frameworks
  • Enhance global safety governance models and compliance programs