Associate Director, Pharmacovigilance Vendor Management

Are you passionate about patient safety Do you have experience within post marketing programs and associated PV regulations

If so now is your chance to join Ascendis Pharma as our new Associate Director Pharmacovigilance Vendor 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 Pharmacovigilance Vendor Management lead to join our growing team. As a key member of the Ascendis Pharma team you will play a crucial role in establishing PV processes in post marketing programs/projects while ensuring compliance with Global PV regulations. 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 Pharmacovigilance Vendor Management team consisting of 4 colleagues and report directly to Peleg Ben-Efraim Director head of Pharmacovigilance Vendor Management teamwho is based in CA will be based in Hellerup Denmark.

Your key responsibilities will be:

• Pharmacovigilance related responsibilities during the initiation conduct and closure of Organized Data Collection programs for marketed products. These activities include but are not limited to:

• Lead pharmacovigilance activities across the lifecycle (initiation conduct closure) of Organized Data Collection programs for marketed products ensuring compliance with global/local regulations and company policies.
• Partner with internal stakeholders to identify and establish PV processes in Organized Data Collection programs and other activities such as Digital Platforms Call Centers and more.
• Provide strategic input to the PV set up and execution in programs including vendor contracts AE handling processes and timelines.
• Ensure effective oversight and performance of service providers/vendors including risk identification monitoring and CAPA implementation.
• Oversee theSDQC and CTV activitiesperformed by service providers/vendorsensuring timely completion and compliance.
• Collaborate closely with GVP Compliance Commercial Medical Affairs and affiliates to ensure consistent and compliant PV practices globally and locally.
• Develop maintain and own global PV processes (e.g. SOPs) and related training materials; deliver PV training to internal and external stakeholders.
• Act as a PV subject matter expert supporting stakeholders and contributing to broader PV activities including vendor oversight areas and crisis management initiatives.

Qualifications and Skills:

You hold a relevant academic degree preferably a Bachelors degree in a health-related discipline and minimum 8 years of Pharmacovigilance experience within the pharmaceutical industry.

Furthermore you have:

• Expert knowledge of FDA safety regulations ICH Guidelines GVP requirements and applicable global pharmacovigilance regulations and guidance.
• Experience operating in cross-functional matrixed environments with the ability to support operational execution compliance oversight and inspection readiness activities.

Key competencies:

You are a strong team player analytical and have a can-do attitude.

You possess an entrepreneurial mindset and can thrive in an informal open environment where innovation and change are key.

To succeed in this role we also expect you to:

• Work independently while having a strong ability to interact as an effective team player encouraging collaboration in a multifunctional and multidisciplinary team setting.
• Demonstrate ability to navigate uncertainty and adapt quickly to changing priorities
• Have track record of delivering results in dynamic fast-paced settings where clarity evolves over time
• Demonstrate ownership initiative and accountability
• Demonstrate holistic thinking and independent decision making

Travel: 10-20 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

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.

Required Experience:

Director