Patient Safety Manager

• 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).

• 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.

• 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.

• 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.

• 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.

• 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

• Master's degree in a relevant field (e.g., Medicine, Pharmacy).

• Minimum of 5 years of experience in clinical trial safety management or pharmacovigilance.
• Familiarity with local and global safety regulations and guidelines.
• Experience collaborating with cross-functional teams and external stakeholders.

Lundbeck