Deadline: March 10, 2024 Drug Safety Associate

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.

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

Your application and CV (in English) should be submitted no later than March 10th, 2023, using the link above.

About Pharmacosmos

Headquartered in Denmark, Pharmacosmos is a family-owned, international healthcare company with more than 50 years of innovation and leadership in iron- and carbohydrate-based treatments and solutions for human and animal use.

A research-based company, its ongoing R&D programme focuses on improving the lives of patients with iron deficiency with or without anaemia. More than 1 billion people live with iron deficiency anaemia and it is the leading cause of death for an estimated 180,000 people every year. This makes it one of the largest global health challenges of our time.

Pharmacosmos has subsidiaries in US, China, UK, Ireland, Germany, Sweden and Norway and its products are marketed in more than 80 countries around the world. Its manufacturing facilities are approved, among others, by the Danish Medicines Agency and the US FDA.

Our Culture

The Executive Leadership Team is headed by Tobias S. Christensen, who is supported by Finance, Marketing and Medical. Additional supporting functions reporting to the CEO are Corporate Development, Legal, Regulatory Affairs, Production and Supply Chain.

The culture of Pharmacosmos is well-established. This is reflected and supported by the company values; people driven, committed to quality and innovating for better lives and by giving people the freedom to make an impact. Consequently, the values guide the everyday work across all countries. They are the compass for the decision-making in both good and challenging times. Also, Pharmacosmos is a business based on trust and is characterized by a strong sense of responsibility. This is the basis for the company’s ambitions as a corporate citizen and its approach to sustainability which is based on a minimum impact on the environment, to ensure safe and healthy working conditions in all locations, to act with integrity and to be in compliance and to build mutual expertise together with partners and stakeholders around the world.


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