Drug Safety Associate

This possition is on behalf of Pharmacosmos in Holbæk.

Are you passionate about patient safety? And 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 Global Drug Safety Operations.
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 Pharmacosmos are expanding their Global Drug Safety Operations team with a new colleague. Read more about their company at the bottom of the page.

About the team

The Global Drug Safety Operations team is a part of the Global Drug Safety organisation which consists of 14 employees and is growing. You will become an important part of the Global 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. Their primary focus is to ensure the patients safety accurately and timely, in accordance with regulatory requirements.
They are a team that works closely together, fostering a sense of an “office family” atmosphere. Team members are skilled at juggling multiple tasks while taking ownership of their responsibilities. Positioned near other key teams such as the Medical Surveillance team and the QPPV office, the team benefits from cross-functional collaboration, gaining insight into how their processed data is utilized in subsequent workflows. This dynamic environment encourages teamwork, adaptability, and a deep connection to the broader impact of their work.

About the job

As the 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 their affiliates and external collaboration partners across the world.
You might come from a similar position and be eager to apply your skills in a new way, or perhaps you are a nurse, pharmaconomist, or medical secretary who would find it motivating to work with patient management in a more data-driven approach.
The responsibilities of the role will vary based on your level of experience and include tasks, such as:

• Case processing: Manage end-to-end processing of individual case safety reports (ICSRs), including downloading cases from authorities, triage, data entry, coding, and documentation in compliance with local regulatory requirements.
• Quality control (QC): Perform detailed quality control of cases and medical evaluation to ensure accuracy and completeness before case submission.
• Reconciliation: Conduct regular reconciliation of safety data with affiliates, license partners, and other stakeholders to ensure consistency and alignment.
• Regulatory reporting: Prepare and submit safety cases within specified timelines.
• Local pharmacovigilance procedures: Contribute to the development and maintenance of local pharmacovigilance procedures.
• Literature searches: Performing worldwide literature searches to identify and capture relevant safety information.
• Collaboration and cross-functional interaction: Work closely with affiliates, surveillance teams, and the QPPV Office, contributing as needed to audit and inspection readiness, as well as to follow-up actions during and after audit or inspections.

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 (e.g. 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.

To succeed in the role of Drug Safety Associate:

• Preferably, you have 2-3 years of experience working with case processing.
• You are confident and proficient in using (IT) tools, databases, and document management systems and the ability to learn appropriate software (Pharmacosmos use HALOPV as a Global Safety Database and Microsoft Office 365).
• You enjoy a wide variety of operational/routine tasks and thrive in a dynamic environment with tight deadlines.
• You are a flexible and supportive team-player as you will be part of a small team.
• You work independently, systematically, and have an eye for – and enjoy working with – details and approach your daily tasks in a structured and organized manner.

Pharacosmos offers

• 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 attractive and competitive compensation package.

Additional Information

This recruitment is assisted by Capax Recruitment. For further information please contact Line Kejser at [email protected]

About the company

Pharmacosmos is considered a world leading authority in treatment of iron deficiency anaemia. Pharmacosmos is a global pharmaceutical company and employs +600 employees globally. Pharmacosmos is headquartered in Holbæk where the majority of the employees work.

Pharmacosmos is a family-owned company with more than 50 years of innovation and leadership in iron- and carbohydrate-based treatments and solutions for human and animal use. Pharmacosmos has subsidiaries in US, UK, Germany and China. For the rest of the world, they are selling through partnerships, making Pharmacosmos products globally present. Its manufacturing facilities are approved, among others, by the Danish Medicines Agency and the US FDA. The products are marketed in around 80 countries. The heritage is Danish, but they work globally.

As 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.

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.