Manager for Pharmacovigilance & Safety
AJ Vaccines
We save lives worldwide. Would you like to join us?
At AJ Vaccines, we are seeking a dynamic and forward-thinking manager to lead our PV & Safety department. If you have a scientific background, extensive knowledge of PV & Safety, and an interest in a leadership role within a lively environment, this position might be for you.
In this hands-on role, you will lead the PV & Safety team and be responsible for the entire PV area, monitoring and ensuring the safety of our vaccines. Join us in our global mission to keep the world safe!
Team Responsibilities and Ambitions
Our team of 6 professionals is a well-functioning, and self-driven group that collaborates and supports each other. We highly value social interactions with a friendly and informal tone. Flexibility in work is a priority for us with options for work-from-home days and self-management of tasks. We handle all tasks related to global PV and safety, ensuring that our operations run effectively.
Role
As the PV & Safety Manager, your responsibility is to facilitate and support the team by overseeing daily administrative, professional, and personnel management. As a key member of the team, collaboration is essential. By facilitating effective teamwork and demonstrating competent leadership, your efforts will be to ensure the continuous development of the PV & Safety team. We expect you to take a hands-on approach to the role where you will be responsible for the entire PV and Safety area. This role could potentially include the position as QPPV.
Your Work Tasks
Your primary responsibilities will be to:
- Manage and supervise the PV & Safety Team according to the strategy and goals set by AJ Vaccines.
- Coordinate roles, responsibilities and tasks across the team.
- Ensure overall compliance of the PV system and stay up-to-date with legislation.
- Participate in daily case-handling and operations.
- Take responsibility for preparation of PSURs, RMPs, product information etc.
- Participate in updating regulatory documents.
- Take the lead during PV inspections and audits.
- Maintain the PSMF, internal PV SOPs, and instructions.
- Support collaboration with agents and distributors, including contractual agreements (SDEAs).
Who Are You?
We are looking for a manager who thrives with people and is eager to build towards the future. We expect you to have a relevant scientific education. You have broad experience within all aspects of pharmacovigilance including case handling and signal detection. Furthermore, you must have extended knowledge of safety regulations and GVP. You possess strong abilities in collaboration and leadership and are motivated by a wish to foster a positive environment for your team members.
We Offer
Join a company with a greater purpose #Together, we keep the world safe. From our headquarters in Copenhagen, we develop and manufacture vaccines, diagnostics, and therapeutic solutions for the world. We are proud to contribute to disease control in more than 50 countries through our collaboration with WHO and UNICEF.
We have a high level of devolved responsibility, and you can have a big impact on your job and professional development. You will meet a lot of passionate co-workers, and you will become a part of a highly skilled and engaging environment. We have a high degree of flexibility and a good work-life balance.
Start Date
We hope to welcome you to your first day at work as soon as possible.
Would You Like to Know More?
If you have any questions or need further information, please contact David Eskelund on: 21304283 or via email on: . If you recognize yourself in the role of Manager for PV & Safety at AJ Vaccines, please apply as soon as possible. We continuously screen and interview candidates and look forward to reading your CV. In AJ Vaccines we do not use cover letters but please add a short introduction in your CV.
Department: Artillerivej 5, København S
