Associate Director/Director, Global PV Operations

Ascendis Pharma

Hellerup, Denmark

As our new Associate Director/Director, Global PV Operations you will become responsible for PV Operations activities and provide strategic and operational PV/quality/safety support for Ascendis Pharma’s portfolio of products in close collaboration with cross-functional colleagues. You will join a dynamic team of PV Professionals, and report directly to the Head of Global PV Operations.

We are seeking a dedicated and experienced Pharmacovigilance (PV) Operations Specialist to join our dynamic team. In this role, you will support our Study Management Teams (SMTs) and act as a key representative for the PV Operations team. You will support product launch initiatives and also oversee PV vendors and service providers, including those for Patient Support Programs and Market Research Programs.

Key Responsibilities:

Support product launch activities in assigned territories;
Collaborate effectively with Study Management Teams (SMTs) as an active member representing the PV Operations team;
Manage and oversee PV vendors and service providers, including those involved in Patient Support Programs and Market Research Programs.

Success Criteria:

Demonstrate the ability to work both independently and collaboratively with team members;
Maintain a few hours of overlapping work hours with colleagues based in Palo Alto, California;
Exhibit strong organizational skills, attention to detail, and adaptability in a fast-paced environment;
Show ownership, initiative, and accountability in all tasks;
Act as an effective team player, fostering collaboration in a multifunctional and multidisciplinary team setting;
Communicate clearly and confidently, both in writing and verbally;
Apply sound strategic evaluation, analysis, and decision-making skills to formulate effective strategies, tactics, and action plans.

Qualifications:

A relevant academic degree, preferably a Bachelor’s degree in a healthcare field;
Several years of documented experience in Pharmacovigilance within the pharmaceutical industry;
Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; global safety regulations knowledge is a plus;
Proficiency in English at a professional level, both written and spoken;
A highly motivated individual who thrives in a collaborative environment and enjoys new challenges.

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