Job Description
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:
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- 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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- 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.
About Lundbeck At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
About Lundbeck At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
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