QPPV & Local Safety Officer KSA
Riyadh, Saudi ArabiaPosted 1 month ago1 open position
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Job Description
Job Title QPPV & Local Safety Officer KSA Function Product Safety Sub Function Pharmacovigilance Location Riyadh, Ar Riyad, Saudi Arabia Date Posted Mar 25 2024 Requisition Number 2406178674W Share
A global leader in health and personal care, with over 125,000 employees in over 275 companies in 60 countries. We work with healthcare partners to touch the lives of more than a billion people every day worldwide.
“By caring, one person at a time, we aspire to help billions of people live longer, healthier, happier lives.”
Johnson & Johnson Innovative Medicine is recruiting for a QPPV & Local Safety Officer in Saudi Arabia. This role will work in a hybrid office/home model based in our Riyadh office.
As a pivotal member of our team, you will foster our dedication to patient safety and drug efficacy as the Qualified Person for Pharmacovigilance (QPPV) and Local Safety Officer. This dual role offers the outstanding opportunity to orchestrate our pharmacovigilance efforts within Saudi Arabia, ensuring our operations not only align with local regulations but also set industry standards for safety and efficacy.
Establish Product knowledge with a focus on safety profiles, Therapeutic Areas and Disease Pathway knowledge supporting the needs of the local operating company in collaboration with the International Medical Safety Officer (MSO) the Country Safety team lead (CSTL), and other partners. Act as a safety expert in cross-functional team meetings and perform training on safety-relevant aspects, as appropriate. Provide Risk Management Plan (RMP) status updates, upon request, and support in the implementation of RMPs and Urgent Safety Restrictions, as needed. Participate in meetings with relevant partners for discussion and evaluation of topics related to benefit-risk and product safety, as required.
Provide medical input and insights for aggregate reports while undertaking local review and ensure the submission of Periodic Safety Update Reports (PSURs/DSURs), as applicable.
Ensure adequate local signal detection process in alignment with the global standards and local regulations.
Ensure timely and compliant safety submissions and to the local health authorities and Health Care Professionals (HCP).
Ensure accurate implementation and maintenance of local business continuity plans with a 24-hours system coverage.
Lead Pharmacovigilance training for internal teams and partners effectively and in timely manner.
Ensure accurate oversight of the local Pharmacovigilance Agreements (PVAs), including Local Safety Unit (LSU) training and adherence to PVAs; Supervise support for vital third-party safety agreements locally, such as local Vendor Agreements, with assistance from central functions like PV Service and Technical Contracts Group.
Stay updated on regulations, ensuring our practices are ahead of the curve. Support the review of new/revised safety regulations, evaluation of the impact on local processes, and notification to the appropriate global and regional groups.
Implement effectively the local Pharmacovigilance System Master File (PSMF), ensure compliance oversight on the procedural document management, and provide insights into metrics to the CSTL, when needed.
Support CSTL in driving the preparation for inspections/audits, addressing follow-up actions from findings, when required
Saudi National, Pharmacist with minimum of four years of proven experience in the pharmaceutical industry, preferably in Pharmacovigilance or Medical Affairs. Scientific/ life-science background, medicinal knowledge preferred; proficiency in Medical terminology (local languages). Ability to manage multiple critical issues. Awareness of and familiarity with industry principles of drug development and pharmacology Good verbal and written communication skills, proficiency in local language(s) and English language required. Ability to communicate proactively and effectively with internal and external customers.
Be part of a team that values innovation and dedication. Here, your work in safeguarding patient safety and enhancing product efficacy is recognized and rewarded. Embrace the opportunity to grow professionally in a supportive, dynamic environment. Demonstrable knowledge of all local PV requirements and of Global aspects of drug safety.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit .
- 基本信息：姓名、生日、民族、性别、国籍、照片；
Basic Information: Name, Birthday, Ethnicity, Gender, Nationality, Headshot;
- 联系信息：住址、电话号码、电子邮件地址；
Contact Information: Address, Phone Number, Email;
- 教育工作信息：职业、职位、工作单位、工作经验、教育背景、学历、学位、培训记录。
Academic & Professional Information: Occupation, Position, Employer, Work Experience, Educational Background, Degree, Training Records.
鉴于强生全球集团业务的全球化经营性质，当您向强生中国应聘职位时，强生中国会按照《应聘者隐私政策》所述情形，向境外接收方及其经授权的第三方提供您的个人信息，包括但不限于：
Due to the global nature of the operation of Johnson & Johnson Family of Companies, in the course of processing your application with J&J China, J&J China may provide your personal information to the overseas recipient and authorized third parties in accordance with J&J’s Careers Privacy Policy, including but not limited to:
除强生中国或法律特别要求外，请您避免在您的申请中提交可能会被视为敏感个人信息的信息，即生物识别、宗教信仰、特定身份、医疗健康、金融账户、行踪轨迹，以及不满十四周岁未成年人的信息等一旦遭遇泄露或非法使用，容易导致人格尊严受到侵害或者人身、财产安全受到危害的个人信息。
Except as specifically requested by J&J China or legally required, please avoid submitting information in your application which may be deemed as sensitive personal information, which includes biometrics, religious belief, specific identity, medical health, financial accounts, whereabouts, as well as information of minors under the age of fourteen (14), and other information that the breach or illegal use of which may easily lead to the infringement of an individual’s personal dignity or harm to personal or property safety.
前述境外接收方为：美国强生公司（Johnson & Johnson Services, Inc.），其联系方式为：美国新泽西州新不伦瑞克市强生广场一号。
The overseas recipient is Johnson & Johnson Services, Inc., which can be contacted at One Johnson & Johnson Plaza, New Brunswick, New Jersey 08933, U.S.
境外接收方将按照如下目的和方式处理您的个人信息。
The overseas recipient will process your personal information in accordance with the following purpose and method:
处理目的：根据强生全球集团“统一人力资源（One HR）”原则，对人才招募进行全球统一管理，具体请参见《应聘者隐私政策》中“我们收集此类个人信息的原因”部分。
Processing Purpose: Conduct talent acquisition management globally following the One HR principle of the Johnson & Johnson Family of Companies, as described in the “Reasons We Collect This Information” section of J&J’s Careers Privacy Policy.
处理方式：通过统一流程和全球互联应用实现对人才招募的统一管理，涉及存储、使用、加工、传输、删除已出境个人信息。境外接收方将采取适当的管理和技术措施保障出境个人信息的机密性、完整性和可用性，并将在完成上述目的最小必要范围内保存出境个人信息。
Processing Method: Conduct talent acquisition management through the unified process and globally connected applications, including storage, use, handling, transmission, and deletion of provided personal information. Overseas recipients will apply appropriate manage
Description
The Johnson & Johnson Family of Companies
A global leader in health and personal care, with over 125,000 employees in over 275 companies in 60 countries. We work with healthcare partners to touch the lives of more than a billion people every day worldwide.
“By caring, one person at a time, we aspire to help billions of people live longer, healthier, happier lives.”
Johnson & Johnson Innovative Medicine is recruiting for a QPPV & Local Safety Officer in Saudi Arabia. This role will work in a hybrid office/home model based in our Riyadh office.
As a pivotal member of our team, you will foster our dedication to patient safety and drug efficacy as the Qualified Person for Pharmacovigilance (QPPV) and Local Safety Officer. This dual role offers the outstanding opportunity to orchestrate our pharmacovigilance efforts within Saudi Arabia, ensuring our operations not only align with local regulations but also set industry standards for safety and efficacy.
*Key Responsibilities:
*Local Medical Safety Responsibility & Benefit Risk Management:
Establish Product knowledge with a focus on safety profiles, Therapeutic Areas and Disease Pathway knowledge supporting the needs of the local operating company in collaboration with the International Medical Safety Officer (MSO) the Country Safety team lead (CSTL), and other partners. Act as a safety expert in cross-functional team meetings and perform training on safety-relevant aspects, as appropriate. Provide Risk Management Plan (RMP) status updates, upon request, and support in the implementation of RMPs and Urgent Safety Restrictions, as needed. Participate in meetings with relevant partners for discussion and evaluation of topics related to benefit-risk and product safety, as required.
*Aggregate reports:
Provide medical input and insights for aggregate reports while undertaking local review and ensure the submission of Periodic Safety Update Reports (PSURs/DSURs), as applicable.
*Signal Detection:
Ensure adequate local signal detection process in alignment with the global standards and local regulations.
*Local Safety Communications
Ensure timely and compliant safety submissions and to the local health authorities and Health Care Professionals (HCP).
*Business Continuity:
Ensure accurate implementation and maintenance of local business continuity plans with a 24-hours system coverage.
*Pharmacovigilance-Safety training support:
Lead Pharmacovigilance training for internal teams and partners effectively and in timely manner.
*PV contract management:
Ensure accurate oversight of the local Pharmacovigilance Agreements (PVAs), including Local Safety Unit (LSU) training and adherence to PVAs; Supervise support for vital third-party safety agreements locally, such as local Vendor Agreements, with assistance from central functions like PV Service and Technical Contracts Group.
*Safety regulations:
Stay updated on regulations, ensuring our practices are ahead of the curve. Support the review of new/revised safety regulations, evaluation of the impact on local processes, and notification to the appropriate global and regional groups.
Local Safety compliance :
Implement effectively the local Pharmacovigilance System Master File (PSMF), ensure compliance oversight on the procedural document management, and provide insights into metrics to the CSTL, when needed.
*Inspection/Audit:
Support CSTL in driving the preparation for inspections/audits, addressing follow-up actions from findings, when required
Qualifications
*Experience and Skills:
Saudi National, Pharmacist with minimum of four years of proven experience in the pharmaceutical industry, preferably in Pharmacovigilance or Medical Affairs. Scientific/ life-science background, medicinal knowledge preferred; proficiency in Medical terminology (local languages). Ability to manage multiple critical issues. Awareness of and familiarity with industry principles of drug development and pharmacology Good verbal and written communication skills, proficiency in local language(s) and English language required. Ability to communicate proactively and effectively with internal and external customers.
Be part of a team that values innovation and dedication. Here, your work in safeguarding patient safety and enhancing product efficacy is recognized and rewarded. Embrace the opportunity to grow professionally in a supportive, dynamic environment. Demonstrable knowledge of all local PV requirements and of Global aspects of drug safety.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit .
- 基本信息：姓名、生日、民族、性别、国籍、照片；
Basic Information: Name, Birthday, Ethnicity, Gender, Nationality, Headshot;
- 联系信息：住址、电话号码、电子邮件地址；
Contact Information: Address, Phone Number, Email;
- 教育工作信息：职业、职位、工作单位、工作经验、教育背景、学历、学位、培训记录。
Academic & Professional Information: Occupation, Position, Employer, Work Experience, Educational Background, Degree, Training Records.
鉴于强生全球集团业务的全球化经营性质，当您向强生中国应聘职位时，强生中国会按照《应聘者隐私政策》所述情形，向境外接收方及其经授权的第三方提供您的个人信息，包括但不限于：
Due to the global nature of the operation of Johnson & Johnson Family of Companies, in the course of processing your application with J&J China, J&J China may provide your personal information to the overseas recipient and authorized third parties in accordance with J&J’s Careers Privacy Policy, including but not limited to:
除强生中国或法律特别要求外，请您避免在您的申请中提交可能会被视为敏感个人信息的信息，即生物识别、宗教信仰、特定身份、医疗健康、金融账户、行踪轨迹，以及不满十四周岁未成年人的信息等一旦遭遇泄露或非法使用，容易导致人格尊严受到侵害或者人身、财产安全受到危害的个人信息。
Except as specifically requested by J&J China or legally required, please avoid submitting information in your application which may be deemed as sensitive personal information, which includes biometrics, religious belief, specific identity, medical health, financial accounts, whereabouts, as well as information of minors under the age of fourteen (14), and other information that the breach or illegal use of which may easily lead to the infringement of an individual’s personal dignity or harm to personal or property safety.
前述境外接收方为：美国强生公司（Johnson & Johnson Services, Inc.），其联系方式为：美国新泽西州新不伦瑞克市强生广场一号。
The overseas recipient is Johnson & Johnson Services, Inc., which can be contacted at One Johnson & Johnson Plaza, New Brunswick, New Jersey 08933, U.S.
境外接收方将按照如下目的和方式处理您的个人信息。
The overseas recipient will process your personal information in accordance with the following purpose and method:
处理目的：根据强生全球集团“统一人力资源（One HR）”原则，对人才招募进行全球统一管理，具体请参见《应聘者隐私政策》中“我们收集此类个人信息的原因”部分。
Processing Purpose: Conduct talent acquisition management globally following the One HR principle of the Johnson & Johnson Family of Companies, as described in the “Reasons We Collect This Information” section of J&J’s Careers Privacy Policy.
处理方式：通过统一流程和全球互联应用实现对人才招募的统一管理，涉及存储、使用、加工、传输、删除已出境个人信息。境外接收方将采取适当的管理和技术措施保障出境个人信息的机密性、完整性和可用性，并将在完成上述目的最小必要范围内保存出境个人信息。
Processing Method: Conduct talent acquisition management through the unified process and globally connected applications, including storage, use, handling, transmission, and deletion of provided personal information. Overseas recipients will apply appropriate manage