373343BR
5月 09, 2023
Vietnam
About the Role
4! The 4 essential elements that shape our culture: Inspired. Curious. Unbossed. Integrity. Our mission is to discover new ways to improve and extend peoples’ lives. Your passion to build, execute business plans to meet the sales goals, develop effective professional business relationships with Healthcare Professionals will help the world understand what these medicines do, why they matter and how Novartis is striving to reimagine medicine.
The role is to support management of Patient Safety operational processes at Country Organization ensuring compliance with Novartis global and local procedures, national and international regulations/ standards/ guidelines for vigilance of both marketed and investigational products from Novartis Group and drive the Novartis POP governance ensuring the local implementation of the Novartis POP standards, policies, guidelines and processes; assess local risks for Novartis related to POPs and establish risk mitigation plans.
Your Responsibilities:
Your responsibilities include, but not limited to:
• Manage the collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from Clinical Trials, Non-interventional Studies, Patient Oriented Program (POPs)s, Literature, Spontaneous Reports, and any other source of information. Transcribe, translate, and enter data from source documents into safety systems accurately and consistently with focus quality and on timeliness.
• Manage reporting/submission/distribution of safety reports/ updates/ information (e.g., SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities (LHA) and/or clinical operations in cooperation with other Country Organization Departments.
• Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements; Prepare and submit KPI reports on compliance in a timely manner including identification of root causes for late reporting to LHA, development and implementation of corrective actions as needed.
• Back-up to other Patient Safety Specialist to perform reconciliation with other departments (e.g. Medical Information, Third party contractors), literature screening as applicable, developing training materials and training of Country Organization Associates on relevant Patient Safety procedures; Onboarding of new Patient Safety associates and mentor less experience Patient Safety associates as applicable.
• Act as POP Champion for local associates involved in POPs, provide advice and guidance; Ensure that the local POP governance is aligned with the Global Governance Office (GGO) and POPs led by the country organization meet patient safety and compliance requirements; Maintain and enhance the Novartis POP standards, policies, guidelines and procedures according to applicable laws and regulations for the respective country organization (or cluster of countries); Manage and oversee POP monitoring activities at country organization or assigned cluster of countries
• Management and distribution of vigilance clauses to other departments (such as Legal, Procurement, etc.) to be included in local agreements if necessary; Develop and deliver training for local associates and management to ensure standards are well understood and followed by all associates involved in the POP process
• Implement controls to measure compliance; review audit outcomes and perform country self-assessments based on defined control matrices; Proactively identify quality and compliance risks related to POPs and establish mechanisms to mitigate these risks in collaboration with Legal, Compliance, Quality Assurance and the Novartis Patient Safety & Pharmacovigilance (PS&PV) organization; Support inspection and audit preparation for health authority inspections, quality audits and internal audits related to POPs and Patient Safety, as needed
• Set-up and execute appropriate corrective and preventive actions plans for self-identified gaps and for audit or inspection findings; Drive change management initiatives and promote a culture of quality, compliance and patient centricity; Participate in cross-functional Governance Boards, global task forces and project teams, as needed
The role is to support management of Patient Safety operational processes at Country Organization ensuring compliance with Novartis global and local procedures, national and international regulations/ standards/ guidelines for vigilance of both marketed and investigational products from Novartis Group and drive the Novartis POP governance ensuring the local implementation of the Novartis POP standards, policies, guidelines and processes; assess local risks for Novartis related to POPs and establish risk mitigation plans.
Your Responsibilities:
Your responsibilities include, but not limited to:
• Manage the collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from Clinical Trials, Non-interventional Studies, Patient Oriented Program (POPs)s, Literature, Spontaneous Reports, and any other source of information. Transcribe, translate, and enter data from source documents into safety systems accurately and consistently with focus quality and on timeliness.
• Manage reporting/submission/distribution of safety reports/ updates/ information (e.g., SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities (LHA) and/or clinical operations in cooperation with other Country Organization Departments.
• Develop, update, and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements; Prepare and submit KPI reports on compliance in a timely manner including identification of root causes for late reporting to LHA, development and implementation of corrective actions as needed.
• Back-up to other Patient Safety Specialist to perform reconciliation with other departments (e.g. Medical Information, Third party contractors), literature screening as applicable, developing training materials and training of Country Organization Associates on relevant Patient Safety procedures; Onboarding of new Patient Safety associates and mentor less experience Patient Safety associates as applicable.
• Act as POP Champion for local associates involved in POPs, provide advice and guidance; Ensure that the local POP governance is aligned with the Global Governance Office (GGO) and POPs led by the country organization meet patient safety and compliance requirements; Maintain and enhance the Novartis POP standards, policies, guidelines and procedures according to applicable laws and regulations for the respective country organization (or cluster of countries); Manage and oversee POP monitoring activities at country organization or assigned cluster of countries
• Management and distribution of vigilance clauses to other departments (such as Legal, Procurement, etc.) to be included in local agreements if necessary; Develop and deliver training for local associates and management to ensure standards are well understood and followed by all associates involved in the POP process
• Implement controls to measure compliance; review audit outcomes and perform country self-assessments based on defined control matrices; Proactively identify quality and compliance risks related to POPs and establish mechanisms to mitigate these risks in collaboration with Legal, Compliance, Quality Assurance and the Novartis Patient Safety & Pharmacovigilance (PS&PV) organization; Support inspection and audit preparation for health authority inspections, quality audits and internal audits related to POPs and Patient Safety, as needed
• Set-up and execute appropriate corrective and preventive actions plans for self-identified gaps and for audit or inspection findings; Drive change management initiatives and promote a culture of quality, compliance and patient centricity; Participate in cross-functional Governance Boards, global task forces and project teams, as needed
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
What you’ll bring to the role:
• Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist), life science degree or equivalent training and experience
• Relevant work experience (min. 5-8 years) in the pharmaceutical industry or public health sector, in the area of patient oriented programs, regulatory affairs, drug development, patient safety or compliance
• Knowledge of national and international regulations for pharmacovigilance; Good awareness about regulatory trends and ability to proactively address needs based on external demands
• Proven track record in leading matrix teams in organizations; High learning agility, comfortable with complexity and diversity
• Excellence in communicating effectively across different audiences and organizational levels
• Excellence in designing and continuously improving business processes to meet quality and compliance standards and to simplify the way we work
• Proven ability to build strong and effective relationships with business partners; Ability to facilitate and influence decision making with local and global senior leaders
Why Novartis?
236 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
• Health Care Sciences Professional (e.g., Medical Doctor, Nurse, Pharmacist), life science degree or equivalent training and experience
• Relevant work experience (min. 5-8 years) in the pharmaceutical industry or public health sector, in the area of patient oriented programs, regulatory affairs, drug development, patient safety or compliance
• Knowledge of national and international regulations for pharmacovigilance; Good awareness about regulatory trends and ability to proactively address needs based on external demands
• Proven track record in leading matrix teams in organizations; High learning agility, comfortable with complexity and diversity
• Excellence in communicating effectively across different audiences and organizational levels
• Excellence in designing and continuously improving business processes to meet quality and compliance standards and to simplify the way we work
• Proven ability to build strong and effective relationships with business partners; Ability to facilitate and influence decision making with local and global senior leaders
Why Novartis?
236 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Global Drug Development
Patient Safety & Pharmacovigilance
Vietnam
Ho Chi Minh City
NVS Vietnam Company Limited
Research & Development
Full Time
Regular
No
