Drug Safety Specialist

Drug Safety Physician

Experience : 5+ Years

Location : PAN India

Qualification: MBBS/MD

Budget : Upto 40 LPA

Relevant experience in Clinical Safety, Pharmacovigilance, Drug Safety, or Clinical Research

Key Responsibilities

• Conduct medical review and scientific evaluation of safety data and literature.
• Perform signal detection, validation, assessment, and contribute to signal management activities.
• Author and review aggregate safety reports, including DSURs, PBRERs, Risk Management Plans (RMPs), and Drug Safety Reports (DSRs).
• Review Clinical Study Reports (CSRs), Individual Case Safety Reports (ICSRs), and provide expert medical input on safety-related matters.
• Ensure compliance with global regulatory guidelines and pharmacovigilance processes.
• Collaborate with cross-functional teams, support audits, and provide medical guidance to stakeholders.
• Contribute to process improvements, scientific discussions, and strategic safety initiatives.

Preferred Skills

Strong knowledge of Pharmacovigilance, Clinical Safety, and Regulatory Affairs

Experience in Signal Management and Aggregate Report Authoring

Excellent scientific writing, analytical, and problem-solving skills

Strong communication and stakeholder management abilities

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