Associate Director – Safety Enablement & Organizational Readiness
Location: Hyderabad / Bangalore / Mumbai, India
Work Model: Hybrid
Category: Senior Manager – Drug & Product Safety Operations
Function: Product Safety | Drug & Product Safety Operations
About the Role
The Associate Director – Safety Enablement & Organizational Readiness is responsible for strengthening pharmacovigilance (PV) capabilities, driving operational excellence, and supporting compliance across Global Medical Safety Operations (GMSO). This role focuses on process improvement, organizational readiness, change management, and safety training initiatives to ensure the organization remains aligned with evolving regulatory expectations and technological advancements.
You will collaborate with cross-functional teams to streamline safety processes, enhance regulatory readiness, support system implementations, and sustain high-quality safety operations.
Key Responsibilities
Operational Excellence & Process Improvement
Implement and improve standardized pharmacovigilance processes and systems in line with global regulatory guidelines.
Identify operational gaps in safety data management, case processing, and reporting workflows.
Maintain and update SOPs, process maps, and related documentation.
Monitor KPIs to support data-driven decision-making and compliance improvement.
Organizational Readiness & Change Management
Support change management activities for new systems, process updates, and regulatory changes.
Conduct impact assessments and assist in communication and training initiatives.
Coordinate feedback mechanisms to evaluate effectiveness and identify enhancement opportunities.
Training & Knowledge Management
Develop and deliver training programs to strengthen PV knowledge across teams.
Maintain learning resources and knowledge repositories to support continuous learning and compliance.
Collaboration & Stakeholder Engagement
Partner with Regulatory Affairs, Clinical Development, IT, and Quality teams to support integrated safety initiatives.
Build strong working relationships with internal and external stakeholders.
Vendor & Project Support
Support vendor oversight activities including performance tracking, issue resolution, and documentation management.
Assist in the planning, execution, and tracking of system implementations and process improvement projects.
Project Management & Process Excellence
Manage multiple projects ensuring adherence to scope, quality, timelines, and cost.
Maintain project dashboards, trackers, and SharePoint sites for GMSO.
Ensure documentation is inspection-ready and aligned with compliance requirements.
Lead communication updates, project reporting, and documentation of lessons learned.
Develop scorecards and dashboards to enhance project transparency and performance tracking.
Qualifications
Education: Bachelor’s degree required; Master’s, PhD, or MBA preferred.
Experience Required:
Minimum 7+ years of experience in pharmacovigilance, drug safety, or a related field.
At least 2+ years of leadership or project management experience in safety operations.
Required Knowledge & Skills
Strong understanding of global pharmacovigilance regulations and operational processes.
Experience in process improvement and change management.
Excellent communication, stakeholder engagement, and interpersonal skills.
Proficiency in MS Office; familiarity with PV systems, safety databases, and analytics tools.
Preferred Skills
Clinical Operations
Compliance Management
Good Clinical Practice (GCP)
Process Improvements
Quality Control (QC)
Risk Management & Safety Investigations
Serious Adverse Event Reporting
SOP Management
Technical Documentation
Medical Device and Drug Development Knowledge
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Siliguri |Illinois :
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Auckland |New Zealand :
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Madrid |Cebu Province :
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Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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