Associate Director, ICSR Management Team - Job ID : 1755NJ

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 Associate Director, ICSR Management Team reports to the Director, Head, ICSR Management Team within the Global Patient Safety (GPS) organization.  Under the direction of the Head, ICSR Management, is responsible for all assigned ICSR Management activities including ICSR processing workflow management, submission and follow-up activities.

Key Responsibilities

• Act as a Subject Matter Expert (SME) with regards to processing of Individual Case Safety Reports (ICSRs) and provide strategic input on case processing activities for Ascendis products.
• Ensures that all safety reports received from any source for Ascendis Products are processed in the safety database and are reported according to ICH-GCP guidelines, Healthy Authority regulations and company SOPs, Work Instructions and Business Partner agreements.
• Responsible for operational activities of ICSRs processed by PV Vendor and provide feedback and guidance as applicable. Assists in the oversight of the PV Vendor processing ICSRs for Ascendis Products.
• Performs Quality Checks of processed ICSRs and provides feedback to PV Vendor as applicable.
• Coordinates follow up activities for missing or ambiguous safety information as appropriate.
• Support vendor oversight by monitoring performance metrics / KPIs.
• Provides input to assigned vendors to improve the quality of Adverse Event intake.
• Performs late case investigation and risk mitigation strategy. Ability to review late case(s) to determine Root Cause Analysis (RCA) and create Corrective Action and Preventative action (CAPA) as applicable.
• Oversee regulatory and departmental compliance by ensuring timely processing of ICSRs in the Safety Database and submission to Health Authorities or partners as applicable.
• Ensure any non-compliance or late ICSR are identified and ensure deviations are filed in accordance with Ascendis requirements.

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Additional activities may include but are not limited to :

Competencies Identified for success :

Requirements

The estimated salary range for this position is $180-195k.  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.