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Role & Responsibilities
• Lead and oversee end-to-end signal management activities including signal detection, validation, prioritization, assessment, and recommendations.
• Provide medical oversight for pharmacovigilance activities in line with global regulatory requirements and internal SOPs.
• Review and approve safety signals, aggregate reports, risk management plans, and safety evaluations.
• Collaborate with global cross-functional teams including Regulatory Affairs, Epidemiology, Clinical, and Biostatistics.
• Support health authority interactions and respond to regulatory queries related to safety and signal management.
• Ensure timely identification, documentation, and communication of emerging safety concerns.
• Provide medical leadership, mentoring, and guidance to safety physicians and PV team members.
• Participate in safety governance forums and contribute to strategic safety decision-making.
Qualifications
• MBBS or MD from a recognized medical institution.
• Strong medical background with understanding of pharmacovigilance and drug safety principles.
Experience
• MBBS with minimum 7+ years of pharmacovigilance experience OR MD with minimum 5+ years of pharmacovigilance experience.
• Minimum 2+ years of hands-on experience in end-to-end signal management.
• Experience working on global safety programs and interacting with international stakeholders preferred.
Skills
• Strong expertise in signal detection, evaluation, and signal management processes.
• In-depth knowledge of global pharmacovigilance regulations and guidelines.
• Excellent medical writing, analytical, and safety assessment skills.
• Ability to work independently in a home-based, global work environment.
• Strong communication, leadership, and stakeholder management skills.
About the Company
• IQVIA is a leading global human data science company serving the healthcare and life sciences industry, IQVIA combines data, technology, analytics, and scientific expertise to drive healthcare innovation worldwide.