Associate Director, Safety Enablement & Organizational Readiness - Hyderabad/Bangalore/Mumbai

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Job Description:

The Associate Director, Safety Enablement & Organizational Readiness supports the development and implementation of initiatives that enhance pharmacovigilance (PV) capabilities, ensure regulatory compliance, and promote operational excellence within Global Medical Safety Operations (GMSO). This role collaborates cross-functionally to drive process improvements, support change management, and facilitate training and knowledge management efforts. The Associate Director plays a key role in ensuring the organization is prepared for evolving regulatory requirements and technological advancements.

Operational Excellence & Process Improvement

• Support the implementation and continuous improvement of standardized PV processes and systems aligned with global regulatory requirements.

• Identify and address operational inefficiencies in safety data management, case processing, and reporting workflows.

• Maintain and update process documentation (SOPs, work instructions, process maps) in collaboration with relevant stakeholders.

• Monitor key performance indicators and support data-driven decision-making to enhance compliance and efficiency.

Organizational Readiness & Change Management

• Assist in the execution of change management strategies related to new systems, processes, and regulatory updates.

• Conduct stakeholder impact assessments and support communication and training initiatives to ensure successful adoption of changes.

• Coordinate feedback mechanisms (e.g., surveys, focus groups) to evaluate the efficiency of change initiatives and identify improvement opportunities.

Training & Knowledge Management

• Develop and deliver role-specific training programs to ensure PV staff are equipped with up-to-date knowledge of regulatory requirements and internal processes.

• Support the creation and maintenance of knowledge repositories and learning resources to promote continuous learning and compliance.

Collaboration & Stakeholder Engagement

• Collaborate with cross-functional teams including Regulatory Affairs, Clinical Development, IT, and Quality Assurance to support integrated safety initiatives.

• Build and maintain effective working relationships with internal stakeholders and external partners to support project execution and knowledge sharing.

Vendor & Project Support

• Support vendor oversight activities, including performance monitoring, issue tracking, and documentation.

• Assist in project planning, execution, and tracking for safety system implementations and process improvement initiatives.

Project Management & Process Excellence

• Manage one or more projects within the constraints of scope, quality, time, and cost to deliver specified requirements to the GMSO organization.

• Partner with internal and external GMSO stakeholders to ensure accurate strategy, plan, alignment, integration, and transparency of departmental project activities.

• Ensure all project requirements, objectives, and deliverables are documented and retrievable to support GMSO’s state of inspection readiness.

• Oversee GMSO project dashboards, project trackers, and departmental SharePoint sites and portals.

• Drive consensus and decision-making with business lines, senior/functional area management, and external stakeholders.

• Monitor and manage project progress, plans, and resources, identifying efficiencies and improvements while maintaining high quality standards.

• Develop departmental dashboards, storyboards, and scorecards to increase transparency and clarity of departmental projects, including key achievement and goal tracking.

• Provide project status reporting and lead the development of stakeholder communications.

• Document project requirements, objectives, technical documents, and lessons learned.

• Ensure archival and retrieval of documentation from an inspection readiness perspective.

Qualifications

• Education: Bachelor’s degree required; advanced degrees (e.g., Master’s, PhD, MBA) preferred.

• Experience: Minimum 7+ years of experience in pharmacovigilance or related field, with at least 2+ years in a leadership or project management role.

Knowledge & Skills

• Strong understanding of global PV regulations and operational processes.

• Experience with process improvement methodologies and change management.

• Excellent communication, collaboration, and interpersonal skills.

• Proficiency in MS Office tools and familiarity with PV systems and analytics platforms.

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