A Career AT Orphazyme
Orphazyme is a development stage biopharmaceutical company. Our highly motivated and talented team of professionals is dedicated to the development of innovative therapeutic approaches to severe diseases, and cooperates with the research community worldwide.
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Senior Pharmacovigilance Specialist
Orphazyme is looking for a Senior Pharmacovigilance Specialist to join our team and build our post-marketing pharmacovigilance system and ensure regulatory compliance. This is your opportunity to join a dedicated team of professionals and become an important part of Orphazyme’s Clinical Safety in a progressive and innovative biopharmaceutical company.
Orphazyme is a listed biotech company based in Copenhagen. We develop new treatment options for orphan protein-misfolding diseases (lysosomal storage and protein-aggregation diseases). Concurrently, we are interacting with regulatory authorities to plan for a marketing authorization application in the beginning of 2020 and we are therefore seeking a Senior Pharmacovigilance Specialist to lead the development of our post marketing pharmacovigilance system.
The job will include the following main responsibilities:
· Lead the development of a post marketing pharmacovigilance system ensuring regulatory compliance in processes and systems such as:
o Designing processes for scientific evaluations and quality assurance in collaboration with the team and collaborators/service providers
o Setting key performance indicators
o Ensuring QPPV oversight
o Contribute to safety agreements
o Be responsible for the PSMF
o Development of training programs
In addition, you will have an important role in ensuring continued marketing authorization of our compounds:
· Performing safety surveillance activities
· Supporting the QPPV in maintaining oversight
· Maintain oversight of regulatory requirements
· Provide operational support to the production of scientific reports (PSURs etc)
· Ensuring appropriate training of the organisation
· Collaboration with service providers
The position will report to the Head of Clinical Safety.
· Great interest in post marketing pharmacovigilance
· You have at least 5 years of pharmacovigilance experience
· You have a relevant scientific background
· Good ability to take initiative, prioritize, multi-task, and work well under pressure to meet deadlines
· You work independently
· You are a team player
· Ability to contribute to documents with consistency and attention to detail
· Clear and systematic thinking that demonstrates good judgment and problem-solving competencies
· Good written and oral communication skills
· Well organized and structured
· Ability to drive projects and deliver results
· Good understanding of global pharmacovigilance requirements and experience in interpretation of the legislation
· Willing to be part of interdisciplinary teams with spirit of initiative and proactivity
We can offer you:
To be part of a small company and a pharmacovigilance department that is developing each day. Orphazyme has an exciting pipeline and a collaborative working environment.
Please apply by sending an email marked “Senior Pharmacovigilance Specialist” with your application and CV to email@example.com. If you have questions about the position, you are welcome to contact Head of Clinical Safety, Marie Aavang Geist at +45 3144 3136.
Our company offers exciting and meaningful career opportunities in an adaptable work environment. We are looking for new colleagues to join our team on the journey towards bringing life-changing therapies to patients who have no satisfactory treatment options today.
We encourage anyone interested in a job to apply, irrespective of gender, age, race, religion, or ethnicity.
We will conduct interviews on an ongoing basis, but final deadline is June 30, 2019. Planned start August 1, 2019.
In general, Orphazyme always welcomes uninvited applications. We ask that the following items are included:
- Curriculum Vitae
- Your motivation for applying to Orphazyme, and why you are a good match with us
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