Associate Director, Pharmacovigilance Projects & Collaborations

Ascendis Pharma; Gentofte Kommune; On-site; DKK 1,000,000 - 1,250,000; Full time

Job summary

Ascendis Pharma is seeking an Associate Director, Pharmacovigilance Projects & Collaborations to establish PV processes in post-marketing programs and ensure compliance with global PV regulations. The role is based in Hellerup, Denmark, leading PV activities across the lifecycle and collaborating with cross-functional, global teams.

You will manage vendor relationships, develop SOPs and training, support crisis management initiatives, and report to the Director, head of Pharmacovigilance Vendor

Qualifications

• Bachelor's degree in a health-related discipline.
• Minimum 8 years of pharmacovigilance experience in pharma.
• Expert knowledge of FDA safety regulations, ICH guidelines, GVP and global PV regulations.

Responsibilities

• Lead pharmacovigilance activities across the lifecycle of Organized Data Collection programs, ensuring compliance with global/local regulations and policies.
• Partner with internal stakeholders to identify PV processes in Organized Data Collection programs and Digital Platforms/Call Centers.
• Provide strategic input to PV setup and execution in programs, including vendor contracts, AE handling, and timelines.
• Ensure effective oversight and performance of service providers/vendors, including risk identification, monitoring and CAPA implementation.
• Oversee SDQC and CTV activities performed by service providers/vendors, ensuring timely completion and compliance.
• Collaborate with GVP Compliance, Commercial, Medical Affairs, and affiliates to ensure consistent 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.

Skills

FDA regulations

ICH Guidelines

GVP requirements

PV regulatory guidance

Cross-functional collaboration

Analytical skills

Education

Bachelor's degree in health-related discipline

Job description

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 Projects & Collaborations.

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 portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.

We are seeking a passionate Associate Director, Pharmacovigilance Projects & Collaborations 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 team, who is based in CA, US. You 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/vendors,ensuring 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 Bachelor's 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

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.

You can learn more about Ascendis by visiting our website www.ascendispharma.com

Applications must be submitted in English and will be treated confidentially.