Drug Safety Associate/Specialist
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Holbæk
Do you want to contribute to patient safety in an innovative pharma company? Do you have pharmacovigilance experience and are you able to keep good oversight of a wide variety of tasks? Then we would like to welcome you to our growing team of dedicated professionals!
Pharmacosmos is a progressive and innovative pharmaceutical company with headquarters in Holbæk, Denmark. We are on an exciting journey of global growth, and therefore we are expanding our capacity with a new colleague to the Drug Safety Department.
The Drug Safety Department is part of R&D at Pharmacosmos. A well-functioning drug safety department is crucial for the success of Pharmacosmos, where the primary focus is to ensure the patients safety accurately and timely, in accordance with regulatory requirements. We are in total 8 experienced and dedicated professionals within the Drug Safety Department, managing global drug safety for our human and veterinary products. You will become an important part of the Drug Safety Operations team of four, working with a wide range of safety operations tasks.
The department is driven by a high level of professionalism, an open-minded approach, where everyone contributes to knowledge sharing, a fun working environment and friendly atmosphere.
As our new Drug Safety Associate (or Specialist) you will have an independent role with a wide variety of operational tasks and responsibilities, dependent on your level of experience. You will work closely with your colleagues in the Drug Safety Department 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.
The position reports to Director Drug Safety.
This include:
You have a relevant, scientific background within natural/health sciences, such as nursing, pharmacy, or the like. We expect you to have previous experience from a pharmaceutical, medical device or biotech company, as a freelance consultant 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 or gastroenterology (clinic or life science industry) is also an advantage.
In addition, we expect you to:
Knowledge of pharmacovigilance systems, case processing and of GVP modules is an advantage.
ONTOPS Recruitment & Development is responsible for the recruitment process on behalf of Pharmacosmos A/S. Further information about the position can be obtained by contacting Recruitment Partner Berit Tops, on +45 2174 2322. Your application and CV (in English) should be submitted as soon as possible and no later than May 1st
Pharmacosmos is a progressive and innovative pharmaceutical company with headquarters in Holbæk, Denmark. We are on an exciting journey of global growth, and therefore we are expanding our capacity with a new colleague to the Drug Safety Department.
About the team
The Drug Safety Department is part of R&D at Pharmacosmos. A well-functioning drug safety department is crucial for the success of Pharmacosmos, where the primary focus is to ensure the patients safety accurately and timely, in accordance with regulatory requirements. We are in total 8 experienced and dedicated professionals within the Drug Safety Department, managing global drug safety for our human and veterinary products. You will become an important part of the Drug Safety Operations team of four, working with a wide range of safety operations tasks.
The department is driven by a high level of professionalism, an open-minded approach, where everyone contributes to knowledge sharing, a fun working environment and friendly atmosphere.
about the job
As our new Drug Safety Associate (or Specialist) you will have an independent role with a wide variety of operational tasks and responsibilities, dependent on your level of experience. You will work closely with your colleagues in the Drug Safety Department 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.
The position reports to Director Drug Safety.
Key responsibilities of the Drug Safety Associate
- Oversight and management of the day-to-day activities regarding cases from marketed human and veterinary products and clinical trials
- Handling individual cases spontaneously reported to Pharmacosmos and clinical trial cases for both human and veterinary products.
This include:
- End-to-end processing of Individual Case Safety Reports including:
- PV mailbox monitoring
- download from authorities
- triage
- data entry
- coding
- medical evaluation of cases according to qualifications
- case submission
- QC 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
about you
You have a relevant, scientific background within natural/health sciences, such as nursing, pharmacy, or the like. We expect you to have previous experience from a pharmaceutical, medical device or biotech company, as a freelance consultant 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 or gastroenterology (clinic or life science industry) is also an advantage.
In addition, we expect you to:
- Have good computer skills (MS Office, Adobe, databases, document management systems) and the ability to learn appropriate software
- Be fluent in English, both written and spoken
- Have a proactive, self-driven and open-minded approach
- Have excellent oversight skills and be well-organized
- Enjoy a wide variety of operational/routine tasks
- Have an eye for detail, accuracy, and quality
- Be a flexible and supportive team-player as you will be part of a small team
- Work independently, systematically and effectively and be flexible
- Bring positive energy, curiosity and good interpersonal skills
- Be capable of assuming responsibility and ownership of own tasks, in a fast-paced environment with changing priorities
Knowledge of pharmacovigilance systems, case processing and of GVP modules is an advantage.
We offer
- An opportunity to join a small pharmacovigilance team with great humor, working with a wide variety of pharmacovigilance tasks
- Cross-functional and cross-cultural collaboration with colleagues and global PV partners
- Inspiring and flexible working environment supported by modern communication technology
- A competitive compensation package
- An exciting role where you can develop your personal and professional competencies and contribute to Pharmacosmos' continued global growth
Additional information
ONTOPS Recruitment & Development is responsible for the recruitment process on behalf of Pharmacosmos A/S. Further information about the position can be obtained by contacting Recruitment Partner Berit Tops, on +45 2174 2322. Your application and CV (in English) should be submitted as soon as possible and no later than May 1st
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 1.4.2022, 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
- Mandag den 30. maj 2022
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