Director - Drug Safety & Pharmacovigilance - Clinical Research Organisation

- The incumbent will be responsible for drug safety, Risk management and ensure the compliance of regulatory requirements with high medical and scientific quality and standards.

- Incumbent provides the medical guidance/decisions for Drug Safety operations.

- Incumbent will also be responsible for setting up services for aggregate reporting, signal detections and risk management and other area.

- This role is a critical part and will play a major role in the development organization, and ultimately responsible, for the pharmacovigilance services for all clients.

- Client Engagement: As a head of PV Services, the Director of PV Services is responsible for risk, revenue, profitability, growth and customer satisfaction of their portfolio.

- Deployment: Monitors the entire lifecycle of client engagements, from initial scoping and contracting through close of the engagement with the customer.

- Resource Management: As a leader of people and teams, the Director, PV Services makes decisions to build teams, develop their skills and improve the overall efficiency and productivity of teams.

- Manages the Safety Case processing, Aggregate reporting, Literature Search, Signal detection and other teams and ensures appropriate information is processed and reported according to ICH-GCP/FDA guidelines, regulatory requirements, and SOPs and procedures.

- Keeps up-to-date on all regulatory guidelines and mentors the PV teams

- Manages, directs and provides strategic leadership to the development, implementation, and continuous improvement of an effective quality assurance program designed to meet Corporate, government and internal standards.

- Manage day-to-day client interaction. Strong project management skills with a keen desire for continual improvement

- Meet and exceed Revenue targets for the departments.

- Ensure proper project execution and minimizes risk on projects

- All other responsibilities as assigned