Manager Case Receipt - Hyderabad / Bangalore

Johnson & Johnson Innovative Medicine • Horsham, PA

4d • Hybrid

About The Position

The Manager Case Receipt is responsible for leading the operational execution and oversight of central case Intake activities within Global Medical Safety Operations. This role ensures timely, accurate, and compliant execution of case receipt, US due diligence, reconciliation, complaint handling, and related pharmacovigilance activities in accordance with global regulatory requirements, company procedures, and quality standards. The Manager partners closely with internal Johnson & Johnson Innovative Medicine stakeholders, external vendors, business partners, Product Quality Vigilance, US Commercial, Local Safety Offices, and other Global Medical Safety Operations functions to drive consistent end-to-end processes, support audit and inspection readiness, monitor operational performance, and advance continuous improvement initiatives that protect patient safety and uphold Johnson & Johnson’s commitment to quality and compliance.

Requirements

• Bachelor’s degree in a health‑related or scientific discipline is required.
• For nurses or pharmacists, active professional licensure/certification (e.g., RN, RPh, PharmD) is required.
• Minimum of 8+ years of pharmaceutical industry or clinical experience with a focus on pharmacovigilance and drug safety, including individual case management is required.
• Demonstrated knowledge of global safety reporting regulations and guidelines and regulatory compliance across the product lifecycle (investigational and post‑marketing environments).
• Proficiency with standard office applications; familiarity with pharmacovigilance safety systems required (ArigGlobal LSMV preferred).

Nice To Haves

• An advanced degree (PhD, PharmD) is preferred.
• Experience working in a high‑volume, regulated operational environment preferred.
• Demonstrated people‑management/collaboration capability, including resource allocation, performance management, hiring, onboarding, staff development, and training within a regulated pharmaceutical setting preferred.

Responsibilities

• Lead daily operational execution and oversight of Global Case Receipt activities, including case receipt, US due diligence, complaint handling, business partner reconciliation, Pharmacovigilance Agreement and associated clinical trial and collaboration agreements and related pharmacovigilance processes to ensure timely, accurate, and compliant execution.
• Manage team capacity, resource needs, workload allocation, staffing priorities, and continuity of business-critical activities to maintain balanced operations and effective service delivery.
• Provide people leadership, including training oversight, development planning, performance support, and adherence to required company standards and training compliance expectations.
• Develop, monitor, and report operational metrics and key performance indicators to assess quality, productivity, compliance, timeliness, vendor performance, and overall process effectiveness.
• Partner with internal GMSO functions, Product Quality Vigilance, US Commercial, Local Safety Offices, business partners, vendors, and other J&J stakeholders to clarify procedures, resolve issues, and drive consistent end-to-end processes.
• Identify and lead process improvement initiatives, system enhancements, and cross-functional projects that improve efficiency, data integrity, compliance, scalability, and long-term operational effectiveness.
• Support audit, inspection, and quality readiness by ensuring documentation is available, participating in reviews or interviews as needed, and contributing to timely responses to findings.
• Lead or support investigations, risk assessments, nonconformance reviews, CAPA activities, and remediation plans to address compliance risks, root causes, trends, and continuous improvement opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager