Medical Safety Scientist
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Holbæk
Due to the impressive growth, Pharmacosmos has decided to expand the Global Drug Safety team. Thus, the role as Medical Safety Scientist is newly established, the position is designed to be highly educational and you will learn the workings of the pharmaceutical industry and more specifically you will be trained within drug safety in relation to post marketing data and clinical development achieving e.g. GCP certification and in depth knowledge on the conduct of clinical trials and the regulatory framework around patient safety. This is a unique role for you who recently graduated as a medical doctor and do not aspire for a clinical career but have a passion for patient safety on a larger scale and would like to help improve people’s health globally from a more scientific role.
You will report directly to Head of Global Drug Safety and Medical Surveillance, Helle von der Recke-Heisel.The team is divided into 4 functions: Operations, QPPV office, PV Technology and partnering, and Medical Surveillance. The team has doubled its size since 2019 and will continue to grow. Currently, the Global Drug Safety organisation consists of 14 employees and this role will report directly to Helle and work very closely with the Medical Safety Directors in the team. The team culture is characterised by fast pace, quality, respect, sharing, flexibility, humour, and social engagement.
The Medical Safety Scientist position is a broad specialist role as the candidate will be responsible for safety aspects of both clinical trial and post marketing activities. This role gives the right candidate an unique opportunity to have influence on vital safety decisions in Pharmacosmos.
The role offers the right candidate great learning opportunities as the candidate will need to take on a broad role and a variation of tasks on both strategic and operational level participating in crossfunctional teams with e.g Clinical Operations, Regulatory Affairs and Medical Affairs.
With the position based at the Pharmacosmos Head Quarter the candidate will be close to key stakeholders of the whole value chain gathered at the same site. The candidate will be exposed to top management and collaborate closely with them and other stakeholders in making the right strategic decisions on the safety agenda and in the preparation of important documents related to patient safety
The Medical Safety Scientist will be part of the Global Drug Safety medical surveillance team responsible for medical safety aspects related to human clinical trials and markedet human medicinal products, incl:
Clinical development tasks (50%):
Post marketing tasks (50%):
Other tasks:
Furthermore, you meet the following personal requirements:
You are determined to do and be your best and take pride in enabling the best work of others on the team
Genux Executive is responsible for the recruitment process on behalf of Pharmacosmos A/S. Further information about the position can be obtained by contacting Recruitment Partner Tina Lorenzen, on [email protected].
Your CV (in English) should be submitted to [email protected] as soon as possible and no later than 28th of February , 2024.
The organisation
You will report directly to Head of Global Drug Safety and Medical Surveillance, Helle von der Recke-Heisel.The team is divided into 4 functions: Operations, QPPV office, PV Technology and partnering, and Medical Surveillance. The team has doubled its size since 2019 and will continue to grow. Currently, the Global Drug Safety organisation consists of 14 employees and this role will report directly to Helle and work very closely with the Medical Safety Directors in the team. The team culture is characterised by fast pace, quality, respect, sharing, flexibility, humour, and social engagement.
The positions
The Medical Safety Scientist position is a broad specialist role as the candidate will be responsible for safety aspects of both clinical trial and post marketing activities. This role gives the right candidate an unique opportunity to have influence on vital safety decisions in Pharmacosmos.
The role offers the right candidate great learning opportunities as the candidate will need to take on a broad role and a variation of tasks on both strategic and operational level participating in crossfunctional teams with e.g Clinical Operations, Regulatory Affairs and Medical Affairs.
With the position based at the Pharmacosmos Head Quarter the candidate will be close to key stakeholders of the whole value chain gathered at the same site. The candidate will be exposed to top management and collaborate closely with them and other stakeholders in making the right strategic decisions on the safety agenda and in the preparation of important documents related to patient safety
Tasks and responsibilities
The Medical Safety Scientist will be part of the Global Drug Safety medical surveillance team responsible for medical safety aspects related to human clinical trials and markedet human medicinal products, incl:
Clinical development tasks (50%):
- Perform medical evaluation of adverse event reports from clinical trials
- Keep oversight of safety data incl. review of laboratory data and test results and perform signal detection
- Safety responsible for clinical trial related documents incl. protocol planning/writing and final Study Report
- Prepare annual safety reports to the authorities
- Take part in Data Monitoring Committees with external medical experts
- Act as Global Medical Safety Monitor in ongoing clinical trials
- Be part of cross functional Clinical Trial Teams
Post marketing tasks (50%):
- Perform medical evaluation of case safety reports related to market medicinal products
- Keep oversight of post marketing safety data and perform signal detection
- Participate in oversight activities related to e.g. safety meetings with Pharmacosmos affiliates
- Prepare aggregated safety reports to the authorities
- Prepare Risk Management Plans
Other tasks:
- Take part in safety review meetings both in relation to data from post marketing and clinical development
- Prepare responses to requests from authorities
- Safety evaluation in relation to potential quality issues
- Write and maintained of Standard Operating Procedures within areas of responsibility
Personal profile
- MD required
- 2-3 years of clinical experience is a plus
- Experience in nephrology, cardiology, hematology is a plus but not required
Furthermore, you meet the following personal requirements:
- Self-driven learner, pragmatic, problem solver, and curious
- Team player, focused on the overall success of the team, the project, and Pharmacosmos
- Strong communicator and good at building professional relations
- Proactive and able to prioritize work in a changing environment
- You are a generous collaborator
You are determined to do and be your best and take pride in enabling the best work of others on the team
Additional information
Genux Executive is responsible for the recruitment process on behalf of Pharmacosmos A/S. Further information about the position can be obtained by contacting Recruitment Partner Tina Lorenzen, on [email protected].
Your CV (in English) should be submitted to [email protected] as soon as possible and no later than 28th of February , 2024.
Information og data
Denne ledige stilling har jobtypen "Forsker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Holbæk.
Jobbet er oprettet på vores service den 6.2.2024, 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.
- Forsker
- Holbæk
- Onsdag den 28. februar 2024
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