Drug Safety Associate
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Hørsholm
ALK is on an ambitious journey to become the preferred allergy company globally and this is why 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 including inspection readiness. We offer a permanent full-time position in the Safety Operations Department within Global Pharmacovigilance, ALK Headquarter in Hørsholm.
Fields of responsibility
Safety Operations manage or are involved in varies of tasks including but not limited to regulatory submission, clinical trial activities, training activities and development activities.
Your qualifications
Personal skills and behaviour
The department/team
Our Safety Operations department consists of 9 passionate colleagues. We always try to develop our competences and processes in order 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 together with colleagues.
The Safety Operations team work closely together with our safety Surveillance team and QPPV office as well as our clinical development department and affiliates.
The position is located at the ALK headquarter in Hørsholm and it is necessary to live in an area where it is possible to commute daily to the office.
We offer
ALK provides a dynamic and pleasant work environment, complete with inspiring and challenging assignments. The results of your efforts will be significant throughout the organization and you will be able to actively influence and challenge the status quo. 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. We consider our pioneering spirit coupled with our trustworthiness our winning formula. ALK is a health focused organization and our offices offer a green view of the DTU Science Park in Hørsholm.
If this sounds like a mission, you also would like to be part of we hope to receive your CV and application no later than 19th of February 2023.
Interviews will take place during the application period.
Contact
For further information on the position please contact Associate Director in Safety Operations Anne Sønderkjøge-Hansen on mobile +45 4068 4097.
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 including inspection readiness. We offer a permanent full-time position in the Safety Operations Department within Global Pharmacovigilance, ALK Headquarter in Hørsholm.
Fields of responsibility
- Entering information from adverse event reports- clinical, post marketing and partner cases- into the ALK safety database according to standard procedures
- Perform verification/QC of cases
- Reconciliation of post-marketing reports between affiliates, partners and distributors and the Global Safety Database
- MedDRA coding of adverse events and medical history for clinical trials
- Reconciliation of SAE reports in the Global Safety Database with the clinical database at the end of study
- Handling of Drug Safety mailboxes
- Close collaboration and support to affiliates globally
- Support internal and external stakeholders
- ICSR Submission to competent authorities
Safety Operations manage or are involved in varies of tasks including but not limited to regulatory submission, clinical trial activities, training activities and development activities.
Your qualifications
- Preferably you have at least 3 years experience within pharmacovigilance (i.e. experience in Individual Case Safety Report (ICSR) data entry, processing, submission, reconciliation and reporting)
- You have an education within health care/life science, e.g. nurse, pharmacist
- Experience with planning and coordination of tasks and optimization of procedures is an advantage
Personal skills and behaviour
- You have an analytic, curious and genuine quality mind-set
- You keep spirits high despite a high workload
- You are proactive and thrive working with tight deadlines
- As a person, you are optimistic, and energetic
- You have good collaboration and communication skills and you are a well organized, structured, flexible, responsible and independent person with a deep sense of ownership
- You have a good sense of humor and enjoy supporting your colleagues
- Good English skills both in writing and verbally
The department/team
Our Safety Operations department consists of 9 passionate colleagues. We always try to develop our competences and processes in order 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 together with colleagues.
The Safety Operations team work closely together with our safety Surveillance team and QPPV office as well as our clinical development department and affiliates.
The position is located at the ALK headquarter in Hørsholm and it is necessary to live in an area where it is possible to commute daily to the office.
We offer
ALK provides a dynamic and pleasant work environment, complete with inspiring and challenging assignments. The results of your efforts will be significant throughout the organization and you will be able to actively influence and challenge the status quo. 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. We consider our pioneering spirit coupled with our trustworthiness our winning formula. ALK is a health focused organization and our offices offer a green view of the DTU Science Park in Hørsholm.
If this sounds like a mission, you also would like to be part of we hope to receive your CV and application no later than 19th of February 2023.
Interviews will take place during the application period.
Contact
For further information on the position please contact Associate Director in Safety Operations Anne Sønderkjøge-Hansen on mobile +45 4068 4097.
Information og data
Denne ledige stilling har jobtypen "Kommunikationsmedarbejder", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Hørsholm.
Jobbet er oprettet på vores service den 10.8.2020, 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.
- Kommunikationsmedarbejder
- Hørsholm
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