Associate Director, Safety Enablement & Organizational Readiness – Hyderabad / Bangalore / Mumbai, India
Employer
Johnson & Johnson (J&J)
Location
Hyderabad, Telangana / Bangalore, Karnataka / Mumbai, Maharashtra – Hybrid Work Model
Function / Sub-Function
Product Safety / Drug & Product Safety Operations
Category
Senior Manager, Drug & Product Safety Operations (P8)
Job Overview
Johnson & Johnson is seeking an Associate Director, Safety Enablement & Organizational Readiness to enhance pharmacovigilance (PV) capabilities and drive operational excellence within Global Medical Safety Operations (GMSO). This role ensures compliance with evolving regulatory standards, strengthens organizational readiness, and fosters a culture of continuous improvement through process optimization, change management, and training initiatives.
The ideal candidate will have 7+ years of experience in pharmacovigilance or related areas, including 2+ years in leadership or project management, with strong expertise in global PV regulations, process improvements, and stakeholder engagement.
Key Responsibilities
Operational Excellence & Process Improvement
Implement and continuously improve standardized PV processes and systems in alignment with global regulatory requirements.
Identify and resolve operational inefficiencies in safety data management, case processing, and reporting workflows.
Maintain and update SOPs, work instructions, and process maps with cross-functional collaboration.
Monitor KPIs to support data-driven decision-making and enhance compliance and efficiency.
Organizational Readiness & Change Management
Execute change management strategies for new systems, processes, and regulatory updates.
Conduct stakeholder impact assessments and support communication and training to ensure smooth adoption of changes.
Coordinate feedback mechanisms such as surveys and focus groups to assess and improve initiatives.
Training & Knowledge Management
Design and deliver role-specific training programs to equip PV staff with up-to-date regulatory and operational knowledge.
Develop and maintain knowledge repositories to promote continuous learning and compliance.
Collaboration & Stakeholder Engagement
Work closely with Regulatory Affairs, Clinical Development, IT, and Quality Assurance teams to support integrated safety initiatives.
Build and sustain effective relationships with internal stakeholders and external partners to ensure successful project execution.
Vendor Oversight & Project Support
Monitor vendor performance, track issues, and maintain documentation.
Assist in planning, executing, and tracking projects related to safety systems and process improvements.
Manage departmental dashboards, trackers, and portals to ensure transparency and alignment across projects.
Project Management & Process Excellence
Lead multiple projects, ensuring delivery within scope, quality, time, and cost constraints.
Drive consensus and decision-making with senior management, business lines, and external stakeholders.
Ensure proper documentation, archival, and retrieval to maintain inspection readiness.
Develop dashboards, scorecards, and reports to track achievements, goals, and key performance indicators.
Qualifications
Education
Bachelor’s degree required; advanced degrees (Master’s, PhD, MBA) preferred.
Experience
Minimum 7+ years in pharmacovigilance, drug safety, or related field.
At least 2 years in leadership or project management roles managing cross-functional teams and process improvement initiatives.
Knowledge & Skills
Strong understanding of global PV regulations and operational processes.
Proficiency in process improvement methodologies and change management.
Excellent communication, collaboration, and interpersonal skills.
Skilled in MS Office tools and familiar with PV systems and analytics platforms.
Preferred Skills
Clinical Operations, Compliance Management, Good Clinical Practice (GCP), Risk Management, Safety Investigations, Serious Adverse Event Reporting, SOP Development, Quality Control (QC), Regulatory Affairs, Medicines and Device Development, OSHA Compliance, Innovation.
Why Join Johnson & Johnson
Contribute to innovative solutions in drug and medical device safety that directly impact patient care.
Engage in cross-functional projects across multiple therapeutic areas with global exposure.
Enjoy a hybrid work environment, professional development opportunities, and access to cutting-edge PV technologies and systems.
Be part of a company committed to healthcare innovation, regulatory compliance, and organizational excellence.
Application Process
Qualified candidates can apply via Johnson & Johnson Careers. J&J is an Equal Opportunity Employer, committed to diversity, inclusion, and providing reasonable workplace accommodations.
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