PV system maintenance (10%)
-Establish and maintain the local Pharmacovigilance (PV) system and Quality Management System (QMS) to comply with China regulatory requirements.
-Update and optimize local Standard Operating Procedures (SOPs) as necessary.
-Compile and update the China Pharmacovigilance System Master File (PSMF).
PV compliance monitoring (20%)
-Monitor monthly China PV Key Performance Indicators (KPIs) and implement Corrective and Preventive Actions (CAPA) when required.
-Manage PV vendors to ensure compliance with local and global pharmacovigilance regulations, contractual obligations, and Lundbeck’s internal procedures.
-Manage deviations related to China PV processes.
-Collaborate with global teams to ensure PV intelligence in China and perform gap analyses of key regulatory requirements.
-Develop inspection readiness procedures and provide support during audits and inspections, including notifying key stakeholders.
-Act as the liaison with Health Authorities (HA) on behalf of Lundbeck Pharmacovigilance Services (PS) for safety-related matters.
Product safety maintenance (10%)
-Local PV Plan and Risk Management:
-Develop local Pharmacovigilance (PV) plans and Risk Management Plans (RMP) in alignment with global/core RMP guidelines.
-Implement and track local risk minimization measures as required.
-Preparation and Submission of PV Documents:
-Review and/or prepare submissions for key local PV documents, including but not limited to: Chinese versions of Periodic Safety Update Reports (PSUR), Development Safety Update Reports (DSUR), Pharmacovigilance System Master Files (PSMF), PV plans, Post-Authorization Safety Study (PASS) plans, and other relevant PV reports.
-Perform submissions as needed.
-Collaboration with Regulatory Affairs (RA):
-Work with China RA to maintain the products, China-specific DSURs, PSUR calendars, and submission trackers.
-Local Product Information (PI) Review:
-Conduct reviews of local PI documents in accordance with Lundbeck’s internal procedures.
-Annual Report Preparation:
-Prepare the PV section of the annual report and support its submission.
-Safety Input for Non-Interventional Studies (NIS) and Real-World Evidence (RWE):
-Provide local safety input for NISs, observational studies, RWE initiatives, and other relevant projects.
-Compliance in Marketing and Product Initiatives:
-Maintain pharmacovigilance compliance for local NISs and any customer-facing marketing or product-related initiatives.
Clinical Trial Safety Management (50%)
-Safety Management Procedures:
--Establish clinical trial safety management procedures in collaboration with cross-functional teams and various stakeholders.
-Ensure compliance with regulatory requirements and internal safety standards during all phases of clinical trials.
-Safety Submission:
--Set up reporting rules with global teams to ensure accurate and timely distribution of safety information to local destinations.
-Monitor and ensure compliance with safety submission requirements during trial development phases, including but not limited to review SUSARs and oversight vendor’s performance.
-Study-Related Material Review:
-Participate in trial level to review local study-related documents, including Safety Management Plans (SMPs), protocols, Investigator Brochures (IBs), Informed Consent Forms (ICFs), and safety reports
-Risk Assessment and Mitigation:
-Conduct safety risk assessments for clinical trials and implement appropriate mitigation strategies to address identified risks.
-Stakeholder Collaboration:
-Collaborate with internal teams (e.g., Regulatory Affairs, Patient Safety, Clinical Operations) and external stakeholders (e.g., vendors, investigators) to ensure seamless safety management processes.
-Act as a liaison between global safety teams and local stakeholders to align safety practices.
-Inspection Readiness and Compliance Monitoring:
-Establish inspection readiness procedures and support audits and inspections related to clinical trial safety.
-Monitor compliance with safety regulations and guidelines, addressing any deviations or gaps promptly.
Standard LPS activities (10%)
-Maintain ADR online reporting account and ensure all product and MedDRA information updated.
-Ensure PS basic training compliance by providing PS trainings to China staffs and external partners.
-Monitor monthly PV training completion status in LMS.
-Organize and perform additional training to cross-functions in Lundbeck China according to yearly training plan.
-Monitor the Lundbeck China mailbox for safety-related communications.
-Ensure document archived according to local regulations and GPS requirement.
-Report cases to local safety mailbox.
-Ensure all the AE source channels are monitored.
-Assess safety risks of customer-facing activities and prepare PV agreement or PV clause for local 3rd party and ensure PVA compliance.
-Build and maintain positive partnerships with internal and external stakeholders.
-Actively participate in team events and activities, taking responsibility for events as needed.
-Mentor new employee and PS intern according to Lundbeck procedure.
-Other tasks assigned by manager.
Role-Specific Competencies
Professional Competencies
-Strong knowledge of clinical trial processes, pharmacovigilance regulations, and safety management practices.
-Expertise in reviewing and managing study-related safety documents.
-Proven ability to conduct risk assessments and implement mitigation strategies.
-Strong structured thinking skills for systematic analysis and problem-solving.
-Strong sense of compliance to ensure adherence to regulatory requirements
Level of Education
-Master’s degree in a relevant field (e.g., Medicine, Pharmacy).
Required Experience
-Minimum of 5 years of experience in clinical trial safety management or pharmacovigilance.
-Familiarity with local and global safety regulations and guidelines.
-Experienc
e co
llaborating with cross-functional teams and external stakeholders.
