Senior Manager, PV Vendor Management Team - Job ID : 1697

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology.

Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues.

Guided by our core values of Patients, Science, and Passion, we use our TransCon® drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.

Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills.

The Senior Manager, PV Vendor Management Team reports to the Director, Head, PV Vendor Management Team within the Global Patient Safety (GPS) organization . Under the direction of the Head, PV Vendor Management Team is responsible for all Vendor Management related activities for assigned vendors. This individual has accountability for the assigned Vendor Management activities in Ascendis.

Key Responsibilities

 Pharmacovigilance related responsibilities over GVP, Patient Support Programs (PSPs) and other Service Providers (SPs) vendors. These activities include, but is not limited to :

• Liaise with functional units to identify Market Research and Patient Support programs (MAPs)
• Ensure all MRP and PSP programs are identified and tracked appropriately
• Provide strategic input on the conduct of MAPs to ensure compliance with PV requirements
• Ensuring SP / vendor oversight under the guidance of Head of PV Vendor Management by contributing to the Vendor Quality Agreements
• Accountable for maintaining oversight over Source data quality check [SDQC] activities and / or Case Transmission Verification (CTV) activities and ensure tracking and timely completion
• Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education / training sessions with functional partners / vendors as required.
• Monitoring GVP and PSP SPs to identify areas of risk and develop strategy and action plans to ensure compliance
• Overseeing and supporting implementation of CAPAs as necessary
• Work Closely with Ascendis GCP / PV Compliance team and Commercial organization as required to ensure oversight of GVP and PSP SPs

 Oversee the GVP vendors / service providers to ensure that they fulfill their accountabilities and responsibilities, which includes, but is not limited to :

 Additional activities may include but are not limited to :

Requirements

Competencies Identified for success :

Education, Experience, and Other Requirements :

The estimated salary range for this position is $175-185 / year.  Actual salary determination is dependent on a variety of factors some of which include : experience, qualifications, and geographic location.  This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package.

Benefits

A note to recruiters :

We do not allow external search party solicitation.  Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources 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.