Quality Management System (QMS) Specialist
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Holbæk
Pharmacosmos is looking for a Quality Management System (QMS) Specialist to join our Drug Safety Department. The QMS Specialist will work closely with the Director QPPV Office to manage the QMS within Drug Safety Department for both Pharmacosmos human and veterinary products.
The Drug Safety Department is part of R&D at Pharmacosmos. We are a small group of seven experienced and dedicated colleagues, managing global drug safety for our human and veterinary products. We are looking forward to welcoming you as an important part of the team in a progressive and innovative pharmaceutical company. You will work closely together with internal stakeholders such as R&D, Quality & Regulatory Affairs, Medical Affairs, Sales & Marketing, as well as with our affiliates and external partners across the world.
Tasks
•Responsible for ensuring that standard operation procedures (SOPs) are in place and maintained
• Responsible for Pharmacovigilance E-learning
• Contribute to compliance monitoring
• Contribute to CAPA management including support closure of CAPAs in relations to SOPs and other quality steering documents
• Perform regulatory surveillance
• Update of systems and processes to ensure QPPV oversight of the Pharmacovigilance system
• Further development of the Pharmacovigilance system and processes for managing the quality of pharmacovigilance function
• Assist with the maintenance of the PSMF
This includes
• Author, update, and review of global and local Pharmacovigilance procedures
• Implementation of partner specific obligations in relevant SOPs
• Monitor Tarius and Safety Observer for new Pharmacovigilance Legislation
• Distribute and track Pharmacovigilance E-learning of Pharmacosmos employees
• Perform KPI QC checks and ad hoc QC checks
• QC of Aggregate Reports
• Contribute to preparation of audits and inspections, be member of the team that interacts with auditors/inspectors and develop Corrective and Preventative Actions (CAPAs) in response to findings/observations in close cooperation with the Director QPPV Office.
• Update PSMF Annexes
The position reports to Director QPPV Office.
As a professional, we expect you to:
As a person we expect you to:
Further information about the position can be obtained by contact Helle Buch Nielsen on, +45 24286056. Your application and CV (in English) should be submitted to us as soon as possible and no later than 10th
About the team
The Drug Safety Department is part of R&D at Pharmacosmos. We are a small group of seven experienced and dedicated colleagues, managing global drug safety for our human and veterinary products. We are looking forward to welcoming you as an important part of the team in a progressive and innovative pharmaceutical company. You will work closely together with internal stakeholders such as R&D, Quality & Regulatory Affairs, Medical Affairs, Sales & Marketing, as well as with our affiliates and external partners across the world.
Key responsibilities of the Drug Safety Operations Manager
Tasks
•Responsible for ensuring that standard operation procedures (SOPs) are in place and maintained
• Responsible for Pharmacovigilance E-learning
• Contribute to compliance monitoring
• Contribute to CAPA management including support closure of CAPAs in relations to SOPs and other quality steering documents
• Perform regulatory surveillance
• Update of systems and processes to ensure QPPV oversight of the Pharmacovigilance system
• Further development of the Pharmacovigilance system and processes for managing the quality of pharmacovigilance function
• Assist with the maintenance of the PSMF
This includes
• Author, update, and review of global and local Pharmacovigilance procedures
• Implementation of partner specific obligations in relevant SOPs
• Monitor Tarius and Safety Observer for new Pharmacovigilance Legislation
• Distribute and track Pharmacovigilance E-learning of Pharmacosmos employees
• Perform KPI QC checks and ad hoc QC checks
• QC of Aggregate Reports
• Contribute to preparation of audits and inspections, be member of the team that interacts with auditors/inspectors and develop Corrective and Preventative Actions (CAPAs) in response to findings/observations in close cooperation with the Director QPPV Office.
• Update PSMF Annexes
The position reports to Director QPPV Office.
About you
As a professional, we expect you to:
- Have min. 3-5 years’ experience from the life science industry in a pharmacovigilance/drug safety/safety surveillance or GVP/GCP function or maybe from the national medical agency.
- Experience with document management systems
- Have good knowledge of Pharmacovigilance systems
- Knowledge of the GVP modules
As a person we expect you to:
- Be pro-active, self-driven, well organized and with good oversight
- Have a positive energy, good interpersonal skills, good sense of humor and able to build sustainable business relations
- Have an eye for detail, accuracy, and quality
- Be a team-player as you will be part of a small team, but at the same time fully capable of assuming responsibility for your own tasks
- Work effectively and be flexible in a fast-paced environment with changing priorities
- Be an exact and precise communicator, fluent in English, both written and spoken
We offer
- An opportunity to join a small pharmacovigilance team with great humor, where you will take part in a wide variety of pharmacovigilance tasks
- Cross-functional and cross-cultural collaboration with colleagues and Pharmacovigilance partners
- Opportunity to be part of Pharmacosmos’ inspiring working environment and continued global growth
- Flexible working environment supported by modern communication technology usages
- An exciting and challenging role where you can develop your personal and professional competencies
Additional information
Further information about the position can be obtained by contact Helle Buch Nielsen on, +45 24286056. Your application and CV (in English) should be submitted to us as soon as possible and no later than 10th
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Holbæk.
Jobbet er oprettet på vores service den 14.12.2020, 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.
- Produktspecialist
- Holbæk
- Søndag den 10. januar 2021
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