Pharmacovigilance & Safety Professional
1 week ago
We save lives worldwide; Would you like to join us?
Are you experienced in Pharmacovigilance & Safety, or are you eager to challenge your interest in this area? Then you may be our next colleague. At AJ Vaccines we are currently looking for a dynamic and skilled new team member who has a strong motivation to join our Pharmacovigilance & Safety Team.
Team Responsibilities and Ambitions
The PV & Safety Team handles all tasks related to global PV & Safety, ensuring that our operations are effective, smooth, and compliant.
We are responsible for the evaluation and global surveillance of our vaccines and other products. The team ensures that a robust system is in place for collecting and communicating drug safety related information to authorities and partners.
We are a well-functioning and self-driven group that collaborates and supports each other with a high level of professionalism. We value social interactions in a friendly and informal atmosphere. Flexibility is a priority, with options for remote work and self-managed tasks.
Your Role
As a PV & Safety Professional your primary role will be to support and maintain an efficient pharmacovigilance system, ensuring adherence to international regulations and compliance with AJ Vaccines’ guidelines, procedures, and SOPs.
Your Work Tasks
You will have a versatile and hands-on position with responsibilities including the following activities:
- Managing all aspects of daily adverse reaction report processing, including receiving, registering, reviewing, archiving, and reporting cases
- Follow-up on reports with health authorities, health care professionals, partners, and customers
- Conducting weekly routine screenings of global scientific literature
- Ensuring compliance with regulations, company procedures, and timelines
- Signal assessment activities on a weekly, monthly, and yearly basis
- Developing and maintaining internal procedures
- Various daily administrative tasks
Your tasks may also, over time, include:
- Taking on the role as PV & Safety product responsible for one or more of AJ Vaccines’ products, including responsibilities such as signal validation and assessment, preparation of PSURs, RMPs, participating in updating of regulatory documents and product information etc.
- Supporting collaboration with agents and distributors, including contractual agreements (SDEAs).
Who Are You?
Your educational background is preferably within health care or pharmaceutical sciences. Experience within the Pharmacovigilance & Safety area is an advantage.
It is crucial that you’re a team player. We depend and rely on each other in the Team, and you must be willing to help and support your colleagues in our mutual endeavor to solve our tasks correctly and timely.
You must be prepared to continuously expand your knowledge of Pharmacovigilance and Safety, as well as our product portfolio.
Deadlines must be met on a weekly basis and it is therefore equally important that you approach tasks with a structured and organized mindset. Attention to detail is essential.
In addition, we expect that:
- You are fluent in written and spoken English
- You master Microsoft tools like Word, Excel, and Outlook
Experience with the use of medical databases will be an advantage.
We Offer
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 both 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.
Interested?
If you recognize yourself in the role as our new Pharmacovigilance & Safety Professional, please don’t hesitate to apply as soon as possible. We continuously screen candidates and look forward to reading your CV. In AJ Vaccines we do not require cover letters. Instead, please include an introduction and motivation directly in your CV.
Would You Like to Know More?
If you have any questions or need further information, please contact Sr. Talent Acquisition Partner, David Eskelund, via email:
Department: Artillerivej 5, København S
#J-18808-Ljbffr-
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