Associate Director, Pharmacovigilance Vendor Management

Ascendis Pharma; Hellerup; On-site; DKK 597,015 - 820,895; Full time

Job summary

Ascendis Pharma in Hellerup, Denmark, is seeking an Associate Director of Pharmacovigilance Vendor Management to ensure compliance with global PV regulations. This role involves leading pharmacovigilance activities and establishing processes in post-marketing programs.

The successful candidate will possess a relevant degree and have over 8 years of experience in pharmacovigilance, demonstrating strong analytical skills and teamwork abilities.

The company values innovation and offers a dynamic work environment dedicated to patient safety.

Qualifications

• Minimum of 8 years of Pharmacovigilance experience.
• Expert knowledge of global pharmacovigilance regulations.
• Ability to support operational execution and compliance oversight.

Responsibilities

• Lead pharmacovigilance activities for Organized Data Collection programs.
• Develop, maintain, and own global PV processes.
• Ensure compliance with global and local regulations.

Skills

Pharmacovigilance experience

Knowledge of FDA safety regulations

Cross-functional collaboration

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 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 apply our innovative TransCon® technology platform to develop new therapies that demonstrate best‑in‑class potential to address unmet medical needs.

Our headquarters are in Hellerup, Denmark, with research facilities in Heidelberg, Germany, and additional offices across Europe and the United States. We advance programs in our Endocrinology, Rare Disease, and Oncology portfolios and collaborate with partners on TransCon‑based products in other therapeutic areas and markets.

We are seeking a passionate Pharmacovigilance Vendor Management lead to join our growing team. You will play a key role in establishing PV processes in post‑marketing programs and ensuring compliance with global PV regulations in a fast‑paced, cross‑functional environment.

You will join the Pharmacovigilance Vendor Management team, consisting of four colleagues, and report directly to Peleg Ben‑Efraim, Director and head of the team located in CA, US. Your base location will be 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 and local regulations and company policies.
• Partner with internal stakeholders to identify and establish PV processes in Organized Data Collection programs and additional 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 the SDQC and CTV activities performed 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 a minimum of 8 years of Pharmacovigilance experience within the pharmaceutical industry.

• 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 a 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

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