Support the development, review, and implementation of Risk Management Plans (RMPs) and additional risk minimisation measures, including effectiveness assessments.
Perform medical and scientific review of safety data, including individual case reports, aggregate reports, and signal management activities.
Ensure accurate and compliant safety data management, reporting, documentation, and quality review.
Support safety listings, aggregate reporting, and signal detection activities.
Ensure regulatory compliance, project quality, and timely delivery of assigned PV activities.
Manage stakeholder communications, project deliverables, and operational escalations.
Support audits, inspections, and continuous process improvement initiatives.
Technology Solutions Support
Assess the impact of system upgrades and enhancements on aggregate reporting, signal detection, and PV workflows.
Collaborate with technology teams to identify, test, and implement system improvements.
People Leadership & Training
Train, mentor, and support team members to ensure quality and compliance.
Identify training needs and support team development and operational management.
Ensure team readiness for audits, inspections, and quality reviews.
Quality & Compliance
Author and review SOPs, work instructions, and controlled documents.
Support audit preparation, coordination, and responses.
Ensure compliance with applicable regulatory requirements, client procedures, and internal quality standards.
Undertake additional responsibilities as assigned by management.
Required Skills & Experience
More than 6 years of pharmacovigilance experience.
Experience in team management, training, and mentoring.
Strong knowledge of global pharmacovigilance regulations and regulatory requirements.
Ability to work independently and manage multiple priorities.
Excellent communication, coordination, and time management skills.
Educational Requirements
Graduate/Postgraduate qualification in a relevant scientific or healthcare discipline, such as B.Pharm, M.Pharm, or BDS, or equivalent.
