Drug Safety Associate

ALK is on an ambitious journey to become the preferred allergy company globally and we are looking for a new colleague to join us.

Is patient safety important to you? Do you want to contribute to development of the pharmacovigilance area in ALK? If so, – this is your chance to be part of a team of dedicated colleagues all working for good pharmacovigilance practice, for the benefit of the allergic patient and for the success of ALK. The team is characterized by motivation and commitment and we strive to help and learn from each other in an informal atmosphere.

We are looking for a Drug Safety Associate who can take part in various tasks related to handling of safety data. We offer a permanent full-time position in the Safety Operations Department within Global Pharmacovigilance, ALK Headquarter in Hørsholm.

Fields of responsibility includes but are not limited to:

• Entering information from adverse event reports- clinical, post marketing and partner cases- into the ALK safety database according to standard procedures
• Reconciliation of post-marketing reports between affiliates, partners and distributors and the Global Safety Database
• Reconciliation of SAE reports in the Global Safety Database with the clinical database at the end of study
• Handling of Drug Safety mailboxes
• Support affiliates globally
• Support internal and external stakeholders
• Submission of individual case safety reports to regulatory authorities
• Maintenance of the Safety Database together with our System and Application Team

Your qualifications

• You have an education within health care/life science, e.g. nurse, pharmacist
• Preferably you have experience within pharmacovigilance (i.e. experience in Individual Case Safety Report (ICSR) data entry, processing, submission, reconciliation and reporting)
• Candidates without experience are also encouraged to apply for the position

Personal skills and behaviour

• You thrive with routine tasks and have a genuine quality mind-set
• As a person, you are optimistic, energetic and proactive in relation to your job
• You have good communication skills and you are a well-organized, flexible, responsible and independent person with a deep sense of ownership
• You have an analytical mind-set
• You have a good sense of humour and enjoy supporting your colleagues
• Good English skills both in writing and verbally

The department/team

ALK provides a uniquely dynamic and pleasant work environment, complete with inspiring and challenging assignments. Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. You will be part of an engaged and informal team who values skill and knowledge creation. The work is flexible and the team shifts between working from home and at our office with a green view at the DTU Scion science park in Hørsholm.

Our Safety Operations department consists of 7 passionate colleagues in Denmark, 4 in the US and 7 in Spain. We always try to develop our competences and processes to meet the needs of the patients and all stakeholders, internally as well as externally. We are driven by a high level of professionalism, integrity, an open-minded approach and contributing to an inspiring and fun working environment.

Deadline 

If you would like to be a part of our team, we hope to receive your CV and application no later than 15. September 2021.

Contact 

If you have any questions, feel free to contact Simon Schmidt on phone 4195 9010 or email sshdk@alk.net