Commercial Eyes- PLG Group of Companies is hiring a Project Lead (Patient Safety) to join its PS & PV Teams. The Project Lead is responsible for the day-to-day operational management and delivery of assigned project portfolio objectives.

Qualifications / Experience / Skills

• BPharm or relevant scientific qualification in disciplines such as Drug Development or Pharmaceutical Sciences.
• Minimum 2 years’ experience in a patient safety or equivalent role in a highly regulated industry e.g., pharmaceutical or devices.
• Minimum 2 years’ experience in clinical trials vigilance
• Experience in adverse event case processing, literature surveillance and other aspects of Patient Safety and clinical trial.
• Minimum 1-2 years of experience in project management.
• Solid experience in regulatory requirements for managing and reporting adverse events in Australia and New Zealand.
• Experience in regulatory requirements for managing and reporting adverse events in Japan, highly desirable
• Highly developed service, communication, organisational and problem-solving skills.
• High level of attention to detail and computer literacy with experience in safety databases.
• Demonstrate independence and initiative to develop and implement solutions.
• Practical experience in SOP writing and document management.
• Consulting experience, preferred

a. General

• Support cross-collaboration within the business by fostering relationships and collaborating with other business units to drive innovation, create efficiencies and expand service offering across the business.
• Provide high quality work that ensures client satisfaction and loyalty, leading to optimisation of repeat business and expansion of service provision

b. Client Management

• Responsible for client set up and contract management.
• Act as the Primary point of contact and Subject Matter Expert (SME), for the project.
• Monitor project progress, track agreed KPI’s and adjust plans as necessary to ensure project goals are met
• Escalate inconsistencies/out of scope requirements to the Senior Manager
• Prepare project reports to ensure project deliverables are met and activities performed by the project team are within the scope of the project
• Assist with preparations for internal and external audits
• Proactive contribution to improving business processes.
• Anticipate regulatory implications of emerging safety issues and offer clients strategies for handling/managing such issues.

c. Resource Management

• Supervision of project team to ensure the smooth delivery of the patient safety and pharmacovigilance service.
• Train and mentor other team members, also to be in line with company needs, client expectations and budget constraints.

d. Patient Safety & Risk Management

• Evaluate adverse events & follow up reports received from various channels and assesses seriousness based on criteria.
• Process & report safety data as per SOP’s and client instructions in order to maintain client and regulatory compliance.
• Act as part of PV & RS Team in line with the scope of the project in order to meet project outcomes and deliverables ensuring compliance.
• Ensure that all potential adverse events or product complaints are appropriately reported and followed-up according to client procedures.
• Maintain the integrity of client safety data registered into GxP databases and associated paper-based systems.
• Participate in the provision of after hour’s safety related telephone services as required by the project scope.

Qualifications / Experience / Skills

• BPharm or relevant scientific qualification in disciplines such as Drug Development or Pharmaceutical Sciences.
• Minimum 2 years’ experience in a patient safety or equivalent role in a highly regulated industry e.g., pharmaceutical or devices.
• Minimum 2 years’ experience in clinical trials vigilance
• Experience in adverse event case processing, literature surveillance and other aspects of Patient Safety and clinical trial.
• Minimum 1-2 years of experience in project management.
• Solid experience in regulatory requirements for managing and reporting adverse events in Australia and New Zealand.
• Experience in regulatory requirements for managing and reporting adverse events in Japan, highly desirable
• Highly developed service, communication, organisational and problem-solving skills.
• High level of attention to detail and computer literacy with experience in safety databases.
• Demonstrate independence and initiative to develop and implement solutions.
• Practical experience in SOP writing and document management.
• Consulting experience, preferred.