Manager, Quality & Compliance Monitoring, QPPV Office
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Søborg
Do you want to play a key role in driving the pharmacovigilance strategy and optimizing the Pharmacovigilance processes and activities? Would you like to be part of one of the most skilled and advanced pharmacovigilance (PV) functions in Denmark? Is setting direction and inspiring a team of highly engaged pharmacovigilance professionals your key competencies and/or passion? If you find these challenges exciting, then you may be our new leader for the “Quality and Compliance Monitoring” team in the QPPV Office, Global Patient Safety, Denmark. Apply today for a life-changing career! The position
In this role, you will play a key role in driving the department strategy as well as executing action plans by driving results through leading a team of PV professionals, who are responsible for monitoring the performance of PV System and ensuring high-quality safety data available to organization by: • Monitoring quality of Individual Case Safety Reports (ICSRs) by establishing manual & automated quality control (QC) checks
• Performing regular trend analysis to identify root causes for identified ICSR quality issues and improve processes to enhance case quality
• Tracking ICSR timeliness compliance to internal and external submission deadlines and escalate any compliance issues for ensure appropriate remedial measures Strong collaboration with other departments within QPPV Office and Global Patient Safety, and our stakeholders in Affiliates and headquarters is essential for the role. You will work in a fast-paced environment reflecting the increasing demands from regulatory authorities while always bearing the patient in mind. Deadlines, cross-functional and inclusive collaboration, and international communication will be part of your workday. You can look forward to setting direction and providing guidance to the team and implementing continuous quality improvement projects. Ensuring safe products and compliance with regulatory requirements is at the heart of 's business. By being part of the QPPV Office you will play a crucial role in driving activities essential for our licence to operate.
Qualifications
To be successful in this position, you should have:
• A master’s degree or PhD in Life Sciences such as Biomedical, Pharmaceutical or Medical Sciences or similar degree
• 7+ years of experience in pharmacovigilance and/or within value chain of pharmaceutical industry with solid knowledge of PV and quality processes
• Prior experience as a people or project manager, who can motivate, develop and empower professionals to achieve business goals
• You are fluent in both written and spoken English As a person, you are enthusiastic, energetic, confident and a strong team player. You can effectively prioritize for yourself and for the team, and cope well under pressure and navigate in uncertainty while maintaining direction and healthy atmosphere for your team. You have demonstrated strategic planning skills and possess strong communication and presentation abilities. You work effectively in a highly matrix team structure and capable of influencing cross-functional working groups. About the department
QPPV Office is an area within Global Patient Safety, located in headquarters (HQ) in Denmark. Global Patient Safety is globally responsible for handling of adverse events and monitoring patient safety in . QPPV Office consists of different departments responsible for various aspect of PV System oversight and support as well as performance monitoring. The primary responsibilities of Quality and Compliance Monitoring team are to provide support to ’s Qualified Person Responsible for Pharmacovigilance (QPPV) by monitoring PV system performance via key performance indicators related to ICSR quality and submission compliance Furthermore, we help other HQ functions and affiliates across by providing PV advice and support on PV quality and compliance related matters.
We use our diversity to generate novel ideas and create high-quality solutions leading to continuous improvement in PV processes to ensure optimal support to the Global Patient Safety and affiliates worldwide in safeguarding the patients using products.
Working at
At , we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Wasim Anwar at +.
Deadline
16 March 2025. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
In this role, you will play a key role in driving the department strategy as well as executing action plans by driving results through leading a team of PV professionals, who are responsible for monitoring the performance of PV System and ensuring high-quality safety data available to organization by: • Monitoring quality of Individual Case Safety Reports (ICSRs) by establishing manual & automated quality control (QC) checks
• Performing regular trend analysis to identify root causes for identified ICSR quality issues and improve processes to enhance case quality
• Tracking ICSR timeliness compliance to internal and external submission deadlines and escalate any compliance issues for ensure appropriate remedial measures Strong collaboration with other departments within QPPV Office and Global Patient Safety, and our stakeholders in Affiliates and headquarters is essential for the role. You will work in a fast-paced environment reflecting the increasing demands from regulatory authorities while always bearing the patient in mind. Deadlines, cross-functional and inclusive collaboration, and international communication will be part of your workday. You can look forward to setting direction and providing guidance to the team and implementing continuous quality improvement projects. Ensuring safe products and compliance with regulatory requirements is at the heart of 's business. By being part of the QPPV Office you will play a crucial role in driving activities essential for our licence to operate.
Qualifications
To be successful in this position, you should have:
• A master’s degree or PhD in Life Sciences such as Biomedical, Pharmaceutical or Medical Sciences or similar degree
• 7+ years of experience in pharmacovigilance and/or within value chain of pharmaceutical industry with solid knowledge of PV and quality processes
• Prior experience as a people or project manager, who can motivate, develop and empower professionals to achieve business goals
• You are fluent in both written and spoken English As a person, you are enthusiastic, energetic, confident and a strong team player. You can effectively prioritize for yourself and for the team, and cope well under pressure and navigate in uncertainty while maintaining direction and healthy atmosphere for your team. You have demonstrated strategic planning skills and possess strong communication and presentation abilities. You work effectively in a highly matrix team structure and capable of influencing cross-functional working groups. About the department
QPPV Office is an area within Global Patient Safety, located in headquarters (HQ) in Denmark. Global Patient Safety is globally responsible for handling of adverse events and monitoring patient safety in . QPPV Office consists of different departments responsible for various aspect of PV System oversight and support as well as performance monitoring. The primary responsibilities of Quality and Compliance Monitoring team are to provide support to ’s Qualified Person Responsible for Pharmacovigilance (QPPV) by monitoring PV system performance via key performance indicators related to ICSR quality and submission compliance Furthermore, we help other HQ functions and affiliates across by providing PV advice and support on PV quality and compliance related matters.
We use our diversity to generate novel ideas and create high-quality solutions leading to continuous improvement in PV processes to ensure optimal support to the Global Patient Safety and affiliates worldwide in safeguarding the patients using products.
Working at
At , we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Wasim Anwar at +.
Deadline
16 March 2025. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 21.2.2025, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Søborg
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Statistik over udbudte apotekere i Søborg over tid
| Dato | Alle jobs som apotekere |
|---|---|
| 2. april 2025 | 12 |
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| 31. marts 2025 | 11 |
| 30. marts 2025 | 13 |
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| 12. marts 2025 | 9 |
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| 7. marts 2025 | 10 |
| 6. marts 2025 | 7 |
| 5. marts 2025 | 9 |
| 4. marts 2025 | 8 |
| 3. marts 2025 | 7 |