Job Description
Are you passionate about Individual Case Safety Report (ICSR) management activities and possess deep knowledge of GVP principles and ICH guidelines? Do you have experience working collaborative with other teams?
If so, now is your chance to join Ascendis Pharma as our new Manager, ICSR Management!
Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients’ lives. Guided by our core values of Patients, Science, and Passion, we are applying our innovative TransCon® technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.
At our headquarters in Hellerup, Denmark, research facilities in Heidelberg, Germany, and additional offices across Europe and the United States, we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.
We are seeking a passionate Manager to join our ICSR Management team. As a member of the Ascendis Pharma team you will play a crucial role in ensuring that all safety reports received from any source for Ascendis products are processed in the safety database and reported according to ICH-GCP guidelines, Health Authority regulations, company SOPs, Work Instructions and business partner agreements.
This is an exciting opportunity to work in a fast-paced environment, collaborate with cross-functional, global teams working together to achieve extraordinary results.
You will be joining the ICSR Management team, being part of the Global Patient Safety organization. You will report directly to the Director, Head of ICSR Management who is based in the US. You will be based in Hellerup.
This is a hybrid position that requires 3 days per week in the office. Since you will join a team based in different time zones, you must be available for evening meetings several times a week. This position also may require occasional international travel.
Your key responsibilities will be:
- Assist in the oversight of the PV vendor that processes ICSRs for Ascendis products, including performing quality review of ICSRs processed by vendor and maintaining metrics on case quality.
- Ensure any non-compliance or late ICSRs are identified and escalated to management.
- Ensure integrity of safety database outputs used for aggregate reports, Health Authority requests or other safety requirements.
- Provide input into departmental SOPs and Work Instructions and ensure compliance with regulatory guidelines and regulations.
- Provide input into training documents used to train vendors on processes for identifying and reporting Adverse Events to Ascendis Global Patient Safety (GPS).
- Support Case Transmission Verification (CTV) and AE Reconciliation activities.
Qualifications and Skills:
You hold a Bachelor’s degree or higher, with a science or health care focus. You have +5 years of recent clinical trial and post-marketing case processing experience.
Furthermore, you have:
- Knowledge of validated Drug Safety databases (Argus preferred)
- Experience with MedDRA coding and global safety reporting regulatory requirements
- Solid foundational knowledge of FDA and EU safety regulations, GVP principles and ICH Guidelines
- Strong organizational skills
- Excellent communication skills, both written and verbal
Key competencies:
You are a team player, encouraging collaboration in a multi-functional and multidisciplinary team setting. You have an analytical mindset and evaluate information critically.
You thrive in an informal, open organization and can quickly adapt in a fast-paced environment.
To succeed in this role, you will need to be curious, self-motivated, responsible and organized.
Travel: approx. 20-30 days per year.
Office: Tuborg Boulevard 12, 2900 Hellerup, Denmark
Apply now.
We evaluate applications when received, so we encourage you to apply as soon as possible. Please note that we conduct interviews on a rolling basis and reserve the right to remove the job posting at any time.
To ensure your application is reviewed, please submit it through the specified platform - applications sent by email or other channels will not be evaluated.
You can learn more about Ascendis by visiting our website www.ascendispharma.com
Applications must be submitted in English and will be treated confidentially.
A note to recruiters:
We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma HR team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs, your ownership of these candidates will not be acknowledged.
