Pharmacovigilance and Quality Assurance Manager

2 days ago

الرياض, Saudi Arabia Ipsen Pharma (SAS) Full time

**Quality Assurance**:

- Act as the local quality assurance/quality system representative for the TSO;
- Establish and maintain TSO Quality Management System and Quality Assurance activities to ensure compliance with all regulatory and GxP requirements;
- Host/Coordinate audits/inspections on behalf of GxP functions within TSO;
- Local supplier assessment and oversight including QTAs maintenance and local audits conduct;
- Ensure Quality management review and KPIs are established;
- Focuses on proactive crisis prevention and supports crisis (QSEB) and CAPA follow-up when needed;
- Facilitate change;
- Drive and support local and global initiatives on continuous quality improvement;
- Drives remediation plan when a product quality or GxP process issue is identified;
- Maintain and ensure local Product Complaints and recalls management;
- Integrate global/corporate and TSO quality needs and priorities, including representing the TSO at the Ipsen Global Quality Forum;
- Foster quality culture by encouraging best practices and a high performing “quality beyond compliance” culture, both from procedural and patient/customer centricity perspectives;
- Contribute strongly to building quality and compliance through governance and education;
- Participate on regulatory intelligence process and, where necessary, escalate with technical expertise, assessment and solution proposals;
- Ensures comprehensive training program covering all GxP activities;
- Ensure the TSO self-inspection, GxP audit readiness; business continuity, change control, Deviations and CAPA management systems and activities are in place and implemented to cover GxP processes;
- Conduct and/or host risk assessments, self-inspections, regulatory inspections, audits.

**PV Roles and Responsibilities**
- Create the local standard operating procedures (SOPs) to handle all the pharmacovigilance activities to be compatible accordance with the regulation on the SFDA variations guidelines
- Ensure all PV activities are delivered in line with local guidelines, legislation as well as local and global Ipsen Policies and SOPs
- Act as the local PV contact for Ipsen Global Patient Safety (GPS)
- Being involved in the causality assessment, seriousness of Individual Case Safety Reports (ICSRs). In addition, ensure the accurate, timely reporting and follow-up activities of all adverse events and special situations reports and have necessary translation and quality steps in place
- Have translation capability
- Ensure review of literature for collection of AEs and Safety Signals
- Escalate any signals identified at local level or highlighted by local health authorities, and any emerging safety concerns
- Compile monthly metric reports and perform weekly/monthly reconciliations for adverse events (internal and with external partners)
- Having awareness of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to safety or the safe use of the products
- Provide Pharmacovigilance oversight to the delivery of Risk Management Plans in conjunction with the cross-functional team and having a sufficient authority over its content, as applicable and ensure aRMMs are managed per global and local requirements
- Ensure the correctness and completeness of pharmacovigilance data submitted to the SFDA
- Ensure a full and prompt response to any request from the SFDA for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product
- Provide Pharmacovigilance expertise into all areas of the business as required.
- Ensure local Ipsen has a comprehensive local PV system
- Work with the quality head for product complaints so that both product complaints and adverse event reports are handled in a compliant and customer service-oriented manner.
- When requested, prepare and review accurate, high quality pharmacovigilance reports (aggregate safety reports and other ad hoc reports) and documentation, within agreed regulatory timelines, to assist in meeting local regulatory requirements, as required under the supervision of GPS, and/or country Leadership.
- Support the business through the provision of drug safety expertise in the review and approval of activities such as Patient Support Programs and Patient Data Collection Systems
- Act as the local contact for all Patient Data Collect Systems (PDCS):

- Provide training and support with regards to PV requirements on PDCS’s to Ipsen colleagues
- Assess program for eligibility and liaise with the GPS solicited team
- Ensure all documentation is completed, PV training is provided, and that the Global Inventory is updated
- Support and attend affiliate/GPS meetings to ensure awareness of any changes in global and/or regional requirements of the PV system.
- Perform regular review of local regulatory requirements and best practices and inform the QPPV Office and/or GRA of any changes to local regulations that affect the reporting of safety data and

  • Pharmacovigilance Associate

    3 months ago

    الرياض, Saudi Arabia Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Manager - IT Quality Assurance

    2 months ago

    الرياض, Saudi Arabia Qiddiya Investment Company Full time

    **Responsibilities**: - Developing Quality Assurance Policies: Implement and follow QA policies and procedures to ensure product quality. - Conducting Audits: Regularly conduct internal audits to ensure compliance with quality standards. - Managing QA Team: Lead and manage the QA team, including raining, and performance evaluations. - Analyzing Data:...

  • Quality Assurance Manager

    2 months ago

    الرياض, Saudi Arabia WSP Full time

    **What if you could do the kind of work the world needs?** At WSP, you can access our global scale, contribute to landmark projects and connect with the brightest minds in your field to do the best work of your life. You can embrace your curiosity in a culture that celebrates new ideas and diverse perspectives. You can experience a world of opportunity and...

  • Quality Assurance Manager

    2 weeks ago

    الرياض, Saudi Arabia HiredAbhi Full time

    We are looking for a skilled Quality Assurance Manager to lead our team of analysts, ensuring that we deliver high quality products in line with our organizational objectives. This role focuses on maintaining high quality standards, driving process improvements, and fostering a culture of excellence within the team. **Main responsibilities** - Supervise...

  • Quality Assurance Engineer

    3 weeks ago

    الرياض, Saudi Arabia D360 Bank Full time

    Quality Assurance Engineer The role is responsible for testing and auditing software and hardware products to ensure they meet stringent quality standards, developing and implementing quality coordination and testing strategy, and recommending solutions to quality issues that arise, ensuring a product is meeting quality requirements before its launch, by...

  • F&b Quality Assurance

    4 days ago

    الرياض, Saudi Arabia Success creators Full time

    We are looking for a detail-oriented quality assurance specialist to be in charge of all quality assurance activities. The quality assurance specialist's responsibilities include developing and implementing quality assurance policies, conducting tests and inspections, identifying production, process, or product issues, and presenting solutions. To be...

  • Quality Assurance Supervisor

    3 months ago

    الرياض, Saudi Arabia mawared hayat Full time

    Pay: ﷼6,000.00 - ﷼8,000.00 per month Application Question(s): - Able to join immediately? - Experience in water companies? **Experience**: - Quality Assurance water Co: 4 years (required)

  • Quality Assurance Specialist

    14 hours ago

    الرياض, Saudi Arabia ASSAF INDUSTRIAL COMPANY Full time

    **Job Overview**: As a Quality Assurance Specialist, you will play a crucial role in maintaining the integrity and quality of our steel products. You will be responsible for developing and implementing quality control systems, conducting inspections, and ensuring compliance with industry standards and customer specifications. This position requires a keen...

  • Senior Quality Assurance Engineer

    1 month ago

    الرياض, Saudi Arabia D360 Bank Full time

    Senior Quality Assurance Engineer The role is responsible for ensuring design quality and adherence to standards. He/she is involved in tasks that include software design, source code development, review and control, configuration management, and integration of software. He/she participates in a wide range of quality assurance testing and analyses to ensure...

  • Lead Specialist, Quality Assurance Ii

    3 weeks ago

    الرياض, Saudi Arabia Ma’aden Full time

    Develop and implement quality management systems (QMS) and procedures to ensure compliance with quality standards, regulatory requirements, and customer expectations. Lead quality audits and inspections of manufacturing processes, facilities, and products to assess compliance with quality standards, identify non-conformities, and recommend corrective...

  • Quality Assurance Specialist

    2 months ago

    الرياض, Saudi Arabia Ninja Food Full time

    We are seeking a detail-oriented and analytical Quality Assurance Specialist to join our Customer Care Department. Key Responsibilities: Review and evaluate customer interactions (chats) to ensure Compliance with company standards and policies. Develop and implement quality assurance processes and metrics. Provide constructive feedback to customer care...

  • Senior Quality Assurance Specialist

    4 months ago

    الرياض, Saudi Arabia OTO Full time

    Hello from OTO, your passport to seamless shipping in the dynamic MENA landscape! As a multi-language, All-in-one Shipping Management Software, we're the navigational tool empowering e-commerce Stores and Omnichannel brands to dispatch their orders effortlessly through a vast network of 200+ shipping companies, both locally and globally. In the quest to...

  • Quality Assurance Engineer Internship Programme

    2 months ago

    الرياض, Saudi Arabia InnovationTeam Full time

    OverviewApplication Share this job **Description**: InnovationTeam is a forward-thinking technology company that specializes in providing innovative solutions to businesses. We are currently seeking a talented Quality Assurance Engineer to join our team. At InnovationTeam, we value innovation, collaboration, and continuous learning. We offer a flexible...

  • Quality Assurance and Accreditation

    2 months ago

    الرياض, Saudi Arabia Alfaisal University Full time

    **Overview**: - Department**College of Business** - Division**QAA** - Job Family**Professional Administration** - Reports to**Dean of College of Business** - Location**Alfaisal University - Riyadh** **Job Summary**: This job is focused on helping the College of Business (CoB) improve its education services and implement best practices. The goal is to align...

  • Quality Manager

    3 months ago

    الرياض, Saudi Arabia Lincoln College International Full time

    **POSITION OVERVIEW**: The Quality Manager will be responsible for developing, implementing, and managing the college's quality assurance systems and processes to ensure high standards in academic and operational performance. This role involves maintaining compliance with accreditation bodies, driving continuous improvement in educational quality, and...

  • Quality Assurance Officer

    3 weeks ago

    الرياض, Saudi Arabia Syarah Full time

    Syarah is on a mission to change how people buy their cars in Saudi and the Middle East. We offer buyers an end-to-end digital car buying experience where they can buy their next car from the comfort of their living rooms. Under the hood, we build systems to manage sourcing of cars, inspection, photography, merchandising, reconditioning, financing,...

  • Quality Assurance/quality Control Engineer

    4 months ago

    الرياض, Saudi Arabia Jadeer Full time

    **Quality Matters!** **We're Hiring a QA/QC Engineer in the KSA!** **About Our Client**: Our client is a renowned construction firm in the KSA, dedicated to delivering projects of the highest quality. They are seeking a meticulous QA/QC Engineer to ensure their projects meet the highest standards. **The Role**: As a QA/QC Engineer, you will be responsible...

  • Regulatory Affairs

    2 months ago

    الرياض, Saudi Arabia Zahrawi Medical Full time

    **About Zahrawi Group**: Zahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE, KSA, Qatar, Bahrain, & Oman markets. The company supplies and distributes high-quality products and services to Hospitals, Clinics, Laboratories, & Analytical Industries. **job Brief**: The incumbent is accountable in management of products...

  • Quality Manager

    3 months ago

    الرياض, Saudi Arabia Marriott International, Inc Full time

    **Job Number** 24169008 **Job Category** Procurement, Purchasing, and Quality Assurance **Location** The Ritz-Carlton Riyadh, AlHada Area, Mekkah Road, Riyadh, Saudi Arabia, Saudi Arabia VIEW ON MAP **Schedule** Full-Time **Located Remotely?** N **Relocation?** N **Position Type** Management **JOB SUMMARY** The position is responsible for implementing...

  • Quality Assurance Specialist Ksa and Gulf Countries

    2 weeks ago

    الرياض, Saudi Arabia Merck Group Full time

    Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich...