Director, QPPV Office
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Holbæk
Are you ready to lead the way in making medicines safer than ever? As Director of the QPPV Office at , you will be in charge of a team that is all about keeping patients safe, ensuring high-quality standards and regulatory compliance, making it a meaningful step in your career
At the heart of Pharmacovigilance lies our QPPV Office, where innovation meets diligence. You will lead a dynamic team, comprising yourself and two specialists, fostering collaboration across departments to uphold the highest standards of drug safety and compliance. You will report directly to Vice President Global Drug Safety, and you will be part of the Global Drug Safety leadership team. The team culture thrives on a fast-paced environment, built on values of respect, knowledge-sharing, and social engagement.
You have a deep passion for pharmacovigilance and a steadfast commitment to ensuring patient safety, high quality, and regulatory compliance. Your robust understanding of pharmacovigilance principles, regulations, and guidelines will be invaluable in this role. Effective communication and interpersonal skills are essential, as you will collaborate closely with cross-functional teams.
While prior experience in people leadership is favourable, it is not a prerequisite. If you have no prior experience, you should be enthusiastic about stepping into a leadership role, while remaining hands-on and deeply involved in the daily tasks. A bachelor’s degree in pharmacy, Life Sciences, or a related field is preferred but not required.
As an individual you are very detail-oriented, ensuring accuracy and compliance in pharmacovigilance tasks. Your strong analytical skills drive you to assess data, identify risks, and spot trends. As a natural leader, you inspire and motivate others toward common goals. Also, you are a strong communicator, adept at conveying complex information to various stakeholders. Lastly, you are adaptable, embracing change and driving improvement to meet evolving needs.
Please send your CV no later than May 28th to att: Tina Lorenzen. We will assess applications continuously. Should you have any questions related to this position, please contact Senior Research Consultant, Tina Lorenzen on tel. or e-mail
About the Job
At the heart of Pharmacovigilance lies our QPPV Office, where innovation meets diligence. You will lead a dynamic team, comprising yourself and two specialists, fostering collaboration across departments to uphold the highest standards of drug safety and compliance. You will report directly to Vice President Global Drug Safety, and you will be part of the Global Drug Safety leadership team. The team culture thrives on a fast-paced environment, built on values of respect, knowledge-sharing, and social engagement.
Key Responsibilities
- QPPV support by overseeing all pharmacovigilance activities, ensuring compliance with global regulations and industry standards,
- Leading the QPPV Office team of two specialists, fostering a culture of excellence, collaboration, and continuous development and improvement,
- Driving the evaluation and implementation of processes to enhance efficiency and effectiveness, for instance compliance through AI solutions,
- Surveillance of international pharmacovigilance regulations and standards
- Support to affiliates,
- Planning and leading pharmacovigilance audits and inspections,
- Deviation and CAPA management,
- QC of key documents,
- Development and compliance with:
- Global and local PSMFs
- KPIs
- Pharmacovigilance training
- SOPs and support QMS activities in QMS system
About You
You have a deep passion for pharmacovigilance and a steadfast commitment to ensuring patient safety, high quality, and regulatory compliance. Your robust understanding of pharmacovigilance principles, regulations, and guidelines will be invaluable in this role. Effective communication and interpersonal skills are essential, as you will collaborate closely with cross-functional teams.
While prior experience in people leadership is favourable, it is not a prerequisite. If you have no prior experience, you should be enthusiastic about stepping into a leadership role, while remaining hands-on and deeply involved in the daily tasks. A bachelor’s degree in pharmacy, Life Sciences, or a related field is preferred but not required.
As an individual you are very detail-oriented, ensuring accuracy and compliance in pharmacovigilance tasks. Your strong analytical skills drive you to assess data, identify risks, and spot trends. As a natural leader, you inspire and motivate others toward common goals. Also, you are a strong communicator, adept at conveying complex information to various stakeholders. Lastly, you are adaptable, embracing change and driving improvement to meet evolving needs.
we offer
- An opportunity to lead and shape the future of pharmacovigilance at a reputable global pharmaceutical company.
- A supportive and collaborative work environment where your contributions are valued and recognized.
- Professional development opportunities to enhance your skills and advance your career.
- The chance to make a meaningful impact on patient safety and public health worldwide.
contact
Please send your CV no later than May 28th to att: Tina Lorenzen. We will assess applications continuously. Should you have any questions related to this position, please contact Senior Research Consultant, Tina Lorenzen on tel. or e-mail
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Holbæk.
Jobbet er oprettet på vores service den 13.5.2024, 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.
- 13.05.2024
- Øvrige
- Holbæk
- Tirsdag den 28. maj 2024
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