Deadline: August 6, 2021 Drug Safety Associate

Do you want to contribute to patient safety in a progressive and innovative pharma company?
Can you keep good oversight of a wide variety of pharmacovigilance tasks? Are you a self-driven teamplayer and do you have a background within health science? Then we have a Drug Safety Associate position open for you!

About the team

The Drug Safety department is part of R&D at Pharmacosmos, a progressive and innovative pharmaceutical company. 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 you will have an independent role with a wide variety of operational tasks. 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 includes:

  • End-to-end processing of Individual Case Safety Reports including:
    • download from authorities
    • triage
    • data entry
    • coding
    • medical evaluation of non-serious cases, and
    • follow-up
  • 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 health science (bachelor level), such as nursing, pharmacy, or the like. Preferably you have 1-3 years’ experience from a pharmaceutical, medical device or biotech company, as a freelance consultant or from regulatory authorities, where you have worked with e.g., drug safety/pharmacovigilance, regulatory affairs, clinical development or another regulated environment. Alternatively, you should have at least 3-5 years’ experience from the clinic. 

Previous experience from comparable pharmacovigilance/safety surveillance/drug safety operational functions will be prioritized. Experience with therapeutic areas within nephrology or gastroenterology (clinic or life science industry) is an advantage.

Also 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 Director Berit Tops, on +45 2174 2322. Your application and CV (in English) should be submitted to us as soon as possible and no later than August 6, 2021. Please use the link in the blue box at the top right and apply through ONTOPS Recruitment & Development. 

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.


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