Commercial Eyes- PLG Group of Companies is hiring a Senior Project Lead and QPPV (Patient Safety) to join its PS & PV Teams. The latter will be responsible for the day-to-day operational management and delivery of assigned project portfolio objectives, as agreed with the Senior Manager.
The role may be required to act as the Qualified Person for Pharmacovigilance (QPPV) and/or the Contact Person for Pharmacovigilance (CPPV) and provide advice on specific pharmacovigilance matters as specified in Client service agreements.
Role Responsibilities:
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 across the Patient Safety & Risk Management service offering.
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 escalate inconsistencies/out of scope requirements to the Senior Manager to ensure projects are delivered on time and within budget.
• 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, and with any allocated follow-up actions.
• Proactive contribution to improving business processes.
• Anticipate regulatory implications of emerging safety issues and offer clients strategies for handling/managing such issues.
• As required, support other teams and other business units.
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 to support smooth transition to the assigned projects.
• Training of project team 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 & RM 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 activities as required by the project scope.
• Perform other Project Specific Responsibilities (PSR) as stipulated in individual Client project(s)
QPPV
• Act as the Qualified Person for Pharmacovigilance (QPPV) and/or Contact Person for Pharmacovigilance (CPPV).
• Ensure compliance with local, global and regional PV regulations, including EMA, FDA, and ICH guidelines.
• Maintain oversight of the pharmacovigilance system and ensure its effectiveness and regulatory compliance.
• Oversee the collection, analysis, and reporting of adverse events and safety data from all sources.
• Ensure timely and accurate submission of periodic safety reports (e.g., PSURs, DSURs) and expedited reports.
• Lead benefit-risk assessments and signal detection activities, ensuring appropriate actions are taken for safety concerns.
• Develop, implement, and maintain Risk Management Plans (RMPs) for all marketed products.
• Collaborate with internal and external stakeholders, including clinical, regulatory, and medical teams, to align on PV strategies
Provide pharmacovigilance expertise to cross-functional teams and senior management.
• Communicate safety-related information to regulatory authorities, healthcare professionals, and the public when necessary.
Qualifications / Experience / Skills
• BPharm or relevant scientific qualification in disciplines such as Drug Development or Pharmaceutical Sciences.
• Minimum 2 years’ experience as Deputy QPPV or PV Contact Person in a drug safety or equivalent role in a highly regulated industry e.g., pharmaceutical or devices.
• Experience in adverse event case processing, literature surveillance and other aspects of Patient Safety.
• Demonstrated experience project managing major/complex projects.
• 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.
• Willingness to travel as required.