Johnson & Johnson Innovative Medicine
Manager Case Receipt - Hyderabad / Bangalore
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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Product Safety
Job Sub Function:
Pharmacovigilance
Job Category:
People Leader
All Job Posting Locations:
Allschwil, Basel-Country, Switzerland, Bangalore, Karnataka, India, High Wycombe, Buckinghamshire, United Kingdom, Horsham, Pennsylvania, United States of America, Hyderabad, Andhra Pradesh, India, Raritan, New Jersey, United States of America
Job Description:
Manager Case Receipt - Hyderabad / Bangalore
Purpose:
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.
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Key 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.
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Qualifications
- Bachelor’s degree in a health‑related or scientific discipline is required. An advanced degree (PhD, PharmD) is preferred.
- 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).
- 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.
- Proficiency with standard office applications; familiarity with pharmacovigilance safety systems required (ArigGlobal LSMV preferred).
- Strong leadership skills with the ability to motivate teams, manage change, and operate with appropriate autonomy and initiative.
Required Skills:
Preferred Skills:
Cross-Functional Collaboration, Developing Others, Global Market, Inclusive Leadership, Leadership, Medicines and Device Development and Regulation, Operations Management, Performance Measurement, Pharmacovigilance, Quality Control (QC), Quality Management Systems (QMS), Regulatory Affairs Management, Report Writing, Safety Investigations, Safety-Oriented, Safety Reporting, Serious Adverse Event Reporting, Team Management
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