Drug Safety Associate
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.
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. Our primary focus is to ensure the patients safety accurately and timely, in accordance with regulatory requirements.
We 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 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.
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.
Mailbox monitoring: Monitor the Global Drug Safety mailbox to promptly process safety-related inquiries and adverse event reports.
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 (we use HALOPV as a Global Safety Database and Microsoft Office 365).
You are fluent in English (professional level), both written and spoken.
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.
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
This recruitment is assisted by Capax Recruitment. For further information please contact Line Kejser at lke@capaxrecruitment.com. Your application and CV (in English) should be submitted no later than 6 January 2025, using the link above.