Drug Safety Associate
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Holbæk
Are you passionate about patient safety? Do you have an eye for detail and are you able to keep good oversight of a wide variety of tasks? Would you like to pursue your drug safety career in an innovative pharma company?
If you can say yes to the above, Pharmacosmos is looking for a Drug Safety Associate to join the Drug Safety Operations team 1st of June 2024.
Pharmacosmos is a global pharmaceutical company with +600 employees globally, with headquarter in Holbæk, DK and subsidiaries in USA, United Kingdom, Germany and China. Pharmacosmos is on an exciting journey of global growth, and right now we are expanding our Drug Safety Operations team with a new colleague. Read more about our company in the right section of the page.
The Drug Safety Operations team is a part of the Global Drug Safety organisation which consist of 14 employees. You will become an important part of the Drug Safety Operations team of five, working with a wide range of safety operations tasks. A well-functioning drug safety function is crucial for the success of Pharmacosmos. Our primary focus is to ensure the patients safety accurately and timely, in accordance with regulatory requirements. We are a team of experienced and dedicated professionals, managing global drug safety for our human and veterinary products.
As our new Drug Safety Associate, you will have an independent and essential role with a wide variety of operational tasks and responsibilities, dependent on your level of experience. You will work closely with your colleagues in Global Drug Safety to manage spontaneous and clinical cases reported on Pharmacosmos human and veterinary products, and tasks related to the Global Safety Database. You will be in regular contact with internal stakeholders, as well as with our affiliates and external collaboration partners across the world.
This includes:
The position reports to the Director, Drug Safety Operations.
You have a relevant background preferably within natural/health related sciences, such as nursing, pharmaconomist or maybe as a medical secretary.
Preferably you have experience from a pharmaceutical, medical device or biotech company, or from regulatory authorities, where you have worked with drug safety/pharmacovigilance/safety surveillance/safety operations. Experience with other regulated life science functions (eg. regulatory affairs, clinical development) and from the clinic is an advantage.
Experience with therapeutic areas within nephrology, cardiology or gastroenterology (clinic or life science industry) is also considered an advantage.
It is essential that you have an eye for – and enjoy working with – details and approach your daily tasks in a structured and organised manner.
In addition, we expect you to:
If you want to know more about the job please contact Marianne Valentin Hansen [email protected]
Your application and CV (in English) should be submitted no later than March 10th, 2023, using the link above.
If you can say yes to the above, Pharmacosmos is looking for a Drug Safety Associate to join the Drug Safety Operations team 1st of June 2024.
Pharmacosmos is a global pharmaceutical company with +600 employees globally, with headquarter in Holbæk, DK and subsidiaries in USA, United Kingdom, Germany and China. Pharmacosmos is on an exciting journey of global growth, and right now we are expanding our Drug Safety Operations team with a new colleague. Read more about our company in the right section of the page.
About the team
The Drug Safety Operations team is a part of the Global Drug Safety organisation which consist of 14 employees. You will become an important part of the Drug Safety Operations team of five, working with a wide range of safety operations tasks. A well-functioning drug safety function is crucial for the success of Pharmacosmos. Our primary focus is to ensure the patients safety accurately and timely, in accordance with regulatory requirements. We are a team of experienced and dedicated professionals, managing global drug safety for our human and veterinary products.
about the job
As our new Drug Safety Associate, you will have an independent and essential role with a wide variety of operational tasks and responsibilities, dependent on your level of experience. You will work closely with your colleagues in Global Drug Safety to manage spontaneous and clinical cases reported on Pharmacosmos human and veterinary products, and tasks related to the Global Safety Database. You will be in regular contact with internal stakeholders, as well as with our affiliates and external collaboration partners across the world.
This includes:
- End-to-end processing of Individual Case Safety Reports including:
- Download from authorities
- Triage
- Data entry
- Coding
- Medical evaluation of cases (according to qualification)
- Case submission
- Quality control of cases
- Follow-up
- Reconciliation with affiliates and partners
- Monitoring individual case safety report compliance and take the necessary corrective actions locally for late reporting
- Performing worldwide literature search
- Contributing to development and maintenance of local pharmacovigilance procedures
- Contributing as required to audit/inspection-readiness and necessary (inter)actions during and post audits/inspections, in close cooperation with the QPPV Office.
The position reports to the Director, Drug Safety Operations.
about you
You have a relevant background preferably within natural/health related sciences, such as nursing, pharmaconomist or maybe as a medical secretary.
Preferably you have experience from a pharmaceutical, medical device or biotech company, or from regulatory authorities, where you have worked with drug safety/pharmacovigilance/safety surveillance/safety operations. Experience with other regulated life science functions (eg. regulatory affairs, clinical development) and from the clinic is an advantage.
Experience with therapeutic areas within nephrology, cardiology or gastroenterology (clinic or life science industry) is also considered an advantage.
It is essential that you have an eye for – and enjoy working with – details and approach your daily tasks in a structured and organised manner.
In addition, we expect you to:
- Be confident and proficient in using (IT) tools, databases and document management systems and the ability to learn appropriate software
- Be fluent in English (professional level), both written and spoken
- Enjoy a wide variety of operational/routine tasks
- Be a flexible and supportive team-player as you will be part of a small team
- Work independently, systematically and effectively
we offer
- An opportunity to join a small and dedicated pharmacovigilance team with great humour and an open and friendly atmosphere
- Inspiring and flexible working environment
- An exciting role where you can develop your personal and professional competencies and contribute to Pharmacosmos' continued global growth
- An attractive and competitive compensation package
Additional information
If you want to know more about the job please contact Marianne Valentin Hansen [email protected]
Your application and CV (in English) should be submitted no later than March 10th, 2023, using the link above.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Holbæk.
Jobbet er oprettet på vores service den 29.6.2021, 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.
- Øvrige
- Holbæk
- Søndag den 10. marts 2024
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