Patient Safety Manager

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%)

1. 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.

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2. 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.

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2. Collaboration with Regulatory Affairs (RA):

• Work with China RA to maintain the products, China-specific DSURs, PSUR calendars, and submission trackers.

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2. Local Product Information (PI) Review:

• Conduct reviews of local PI documents in accordance with Lundbeck's internal procedures.

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2. Annual Report Preparation:

• Prepare the PV section of the annual report and support its submission.

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2. 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.

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2. 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%)

1. Safety Management Procedures:

1. • 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.

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2. Safety Submission:

1. • 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.

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2. 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
3. Risk Assessment and Mitigation:
   • Conduct safety risk assessments for clinical trials and implement appropriate mitigation strategies to address identified risks.
4. 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.
5. 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.
• Experience collaborating with cross-functional teams and external stakeholders.