Director, Drug Safety is the vertical lead of the Drug Safety Services (DSS) department and is responsible for leading the entire lifecycle of drug safety projects, from initial scoping and contracting through close of the engagement with the client. The role holds responsibility for risk, revenue, profitability, growth, and customer satisfaction. The role requires relevant medical knowledge and strong, current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Strategic Leadership & Business Management
- Lead the development and execution of short-term and long-term strategic plans for the Pharmacovigilance (PV) Projects portfolio, ensuring alignment with organisational objectives, regulatory requirements, business growth and client expectations.
- Define and drive the strategic direction of PV project delivery, ensuring operational excellence, scalability, consistency and sustained client satisfaction across global engagements.
- Provide strategic oversight of complex and large-scale PV projects, including new client onboarding, project transitions, operational integrations, service expansions and transformation initiatives.
- Establish and implement robust governance frameworks, operational models and performance management strategies to ensure consistent delivery across the PV portfolio.
- Identify emerging business needs, operational challenges and industry trends, translating them into actionable strategies to strengthen service capabilities and competitive positioning.
Operational Excellence & Performance Management
- Drive operational performance through the effective utilisation of KPIs, SLAs, quality metrics and data analytics to identify performance trends, operational risks and opportunities for continuous improvement.
- Lead initiatives to optimise PV processes, enhance productivity, improve quality and leverage technology and automation to strengthen operational efficiency.
- Establish mechanisms for proactive risk identification, issue resolution, escalation management and mitigation of potential delivery and compliance risks.
- Ensure effective oversight of project deliverables, timelines, budgets, resource utilisation and contractual commitments across the assigned portfolio.
- Promote process harmonisation, standardisation and implementation of best practices across global PV operations.
Resource Planning & Organisational Development
- Forecast project pipeline, business growth, resource requirements and recruitment needs, ensuring appropriate workforce planning and resource allocation.
- Develop scalable organisational structures and delivery models to support business expansion, new project acquisitions and evolving client requirements.
- Provide leadership in talent acquisition, workforce development, succession planning and retention of key resources.
- Oversee people management activities, including performance evaluation, capability development, leadership mentoring, compensation planning and employee engagement, in accordance with organisational policies.
- Build and lead high-performing, multidisciplinary teams, fostering accountability, collaboration, ownership and a strong quality-driven culture.
Client Relationship & Stakeholder Management
- Serve as a senior escalation point and strategic partner for key clients, developing and maintaining strong relationships with senior client stakeholders.
- Proactively manage client expectations, identify potential concerns and drive timely resolution of operational, contractual and quality-related escalations.
- Lead strategic business reviews, governance meetings and performance discussions, providing insights into project performance, risks, improvement opportunities and future business needs.
- Establish strong cross-functional partnerships with Quality Assurance, Regulatory Affairs, Clinical Operations, Business Development, Finance, Human Resources, IT and other internal stakeholders.
- Influence senior management and client stakeholders through effective communication, negotiation and evidence-based decision-making.
Business Development & Commercial Management
- Partner with Business Development and Commercial teams to drive business growth through operational inputs into RFPs, RFIs, proposals, presentations, solution design and Statements of Work (SOWs).
- Provide strategic inputs into service pricing, resource modelling, project feasibility assessments, transition plans and operational delivery models.
- Identify opportunities for account expansion, cross-selling, service diversification and development of new PV capabilities.
- Ensure alignment between contracted scope, operational delivery, resource commitments and financial expectations.
- Support commercial reviews, budget management, revenue forecasting and identification of opportunities to improve project profitability and operational sustainability.
Pharmacovigilance & Regulatory Oversight
- Provide strategic oversight across assigned PV services, including ICSR management, aggregate reporting, signal detection and management, risk management, medical literature surveillance, safety systems and QPPV-related services, as applicable.
- Maintain advanced knowledge of global pharmacovigilance regulations, GVP requirements, clinical development processes, clinical research methodologies and evolving regulatory expectations.
- Ensure that PV project delivery models incorporate appropriate quality controls, regulatory compliance measures, inspection readiness and robust documentation practices.
- Drive the development and implementation of organisational policies, procedures, governance frameworks and operational standards to support compliant and consistent service delivery.
- Provide strategic guidance on complex PV operational and compliance challenges, ensuring appropriate escalation, risk mitigation and resolution.
Leadership & Organisational Influence
- Provide strategic direction and leadership to Directors, Project Managers, Delivery Partners, Client Partners and other senior operational leaders across assigned functions and business units.
- Demonstrate strong leadership in organisational change management, business transformation, process improvement and operational integration initiatives.
- Communicate complex business, operational and regulatory concepts effectively to multidisciplinary teams and senior management stakeholders.
- Influence decision-making at multiple organisational levels and establish credibility as a trusted business and operational leader.
- Represent the organisation in strategic client engagements, business reviews, industry forums and other relevant external interactions.
PREFERRED SKILLS:
- 10-12 years of Drug Safety or relevant experience and at least 8 years of people and project management experience.
- In-depth knowledge and understanding of Drug Safety/Pharmacovigilance regulations with respect to pharmaceutical drugs and other related products.
- Strong organizational, documentation, and interpersonal skills needed to interact effectively with clients, management, peers and cross-functional teams effectively.
- Good working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines.
- Experience with safety data collection and interpretation originating from clinical trials and other sources (such as literature, solicited reports and the post-marketing setting).
- Ability to build relationships, collaborate and influence across disciplines within Sitero and with outside stakeholders.
- Excellent verbal, written and presentation skills.
- Innovative, collaborative and proactive.
COMPENSATION & BENEFITS:
Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, variable pay, paid time off, and healthcare and retirement benefits.
EMPLOYMENT TYPE:
Full Time, permanent
COMMITMENTS:
- Standard Hours: 40 hours per week, Monday – Friday with one hour lunch break. Additional hours as required.
- Willingness to work shifts as and when required.