Senior Manager – DSRM (Medical Reviewer)
Location: Airoli, Maharashtra, India
Company: Lupin
Date Posted: January 26, 2026
Employment Type: Full-Time
Industry: Pharmacovigilance | Drug Safety Risk Management | Medical Review
About the Role
Lupin is seeking a Senior Manager – DSRM (Medical Reviewer) to lead medical review and signal management activities within the Drug Safety and Risk Management (DSRM) function. This role involves oversight of pharmacovigilance processes, signal detection, aggregate report evaluation, and clinical safety review, with a focus on ensuring regulatory compliance, high-quality medical review, and team development.
The ideal candidate will have extensive experience in pharmacovigilance, clinical safety, signal detection, and aggregate reporting, combined with the ability to mentor teams and contribute to process improvements and SOP development.
Experience Required
5–10 years of experience in pharmacovigilance
Expertise in:
Aggregate report preparation and review
Signal detection and evaluation
Clinical safety and SAE management
Medical review of Individual Case Safety Reports (ICSRs)
Educational Qualification (Mandatory)
Doctorate (MD) / Graduation in Medicine
Key Responsibilities
Medical Review & Signal Management
Oversee and manage medical review activities for health hazard assessments and signal detection
Review and approve Individual Case Safety Reports (ICSRs)
Provide inputs for Post Procedure Quality Checks (PPQC) and case documentation
Evaluate literature for aggregate reports and signal management activities
Team Oversight & Training
Provide guidance, training, and knowledge sharing for the DSRM team
Support team in preparing device malfunction reports and drafting responses for Health Authority queries
Mentor team members in medical review standards and pharmacovigilance best practices
Quality & Compliance
Review and approve quality investigation reports and case deletion forms
Provide input for SOPs, guidance documents, and process improvement initiatives
Ensure all activities comply with global pharmacovigilance regulations and internal quality standards
Required Skills & Competencies
Strong expertise in pharmacovigilance, clinical safety, and aggregate reporting
Ability to analyze complex safety data and provide scientific medical input
Excellent leadership and mentorship skills
Strong collaboration and stakeholder management capabilities
Innovation-driven approach for process improvement and efficiency
Core Competencies
Innovation & Creativity
Result Orientation
Developing Talent & Mentorship
Process Excellence
Collaboration & Teamwork
Stakeholder Management
Why Join Lupin?
Lead a high-impact pharmacovigilance and DSRM function
Drive medical review, signal detection, and clinical safety activities
Mentor and develop teams in a global regulatory-compliant environment
Contribute to process excellence, SOP development, and quality improvement initiatives
Equal Opportunity Statement
Lupin is committed to providing equal employment opportunities across recruitment, compensation, promotion, and professional development. All qualified candidates will be considered in accordance with applicable regulatory and employment standards.
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