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 Director, Head, ICSR Management Team reports to the Head, Global PV Operations within the Global Patient Safety (GPS) organization. Under the direction of the Head, Global PV Operations, the Director, ICSR Management Team is responsible for the oversight of all ICSR Management activities including ICSR processing workflow management, submission and follow-up activities. He/She is responsible for the leadership and management of the strategic and operational job activities pertaining to the ICSR Management team.

Key Responsibilities

People Management: Establish and manage a team of ICSR Management Leads working on a diverse scope of activities to ensure pharmacovigilance regulations/ guidelines are adhered to
Responsible for managerial oversight of the ICSR Management team with regards to budget, headcount, people and organizational development
Participates with senior management to establish strategic plans and objectives
Acts as an integral member of the Global Patient Safety (GPS) leadership team
Works closely with the Head, Global PV Operations to be aware of all safety issues/concerns and provide consultation when needed
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
Accountable for the data integrity of safety data outputs from the Safety Database for aggregate reports, Health Authority requests or other safety requirements
Liaise with other functional groups for implementation of PV related processes requiring cross functional collaboration
Drafts and updates departmental SOPs, Work Instruction etc. as applicable and ensure compliance with regulatory guidelines and regulations
Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)
Responsible for training GxP vendors on processes corresponding to identification and reporting of Adverse Events to Ascendis Global Patient Safety
Functions as a PV advisor to Ascendis Clinical Development Organizations, Medical Affairs, Commercial Organizations and PV staff as applicable
Identify opportunities for process improvements and participate in process optimization initiatives
Support Medical Safety Science team with activities related to signal detection, risk management and health authority responses as needed
Raise or increase awareness, knowledge and understanding of pharmacovigilance requirements by conducting education/training sessions with functional partners / vendors as required
Supports Case Transmission Verification (CTV) and SAE Reconciliation activities as needed
Collaborate with PV Information Technology team on implementation and maintenance of the Global Safety Database and Safety Reporting rules within the Safety Database
Reviews and provides input to Business Partner or Pharmacovigilance Agreements and Safety Data Exchange Agreements (SDEA) to ensure appropriate safety exchange requirements are established and adhered to
Responsible for the creation, maintenance and implementation of the Business Continuity Plan (BCP ) as needed

Additional activities may include but are not limited to:

Contribute to the maintenance of Ascendis Pharmacovigilance System Master File (PSMF)
Through coordination with Ascendis GCP and PV Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits
Work collaboratively with Vendor Management, PV Study Management, QPPV Office and Medical Safety Science teams for assigned activities
Is responsible for any assigned US applicable Risk Management Plan Implementation Coordination activities and associated tracking as necessary
Maintain selected oversight of activities within the scope of Ascendis PV group under the direction of Head, ICSR management (example: Local PV agreements, CRMs, Digital Media etc.)
Participate in relevant crisis management activities within the scope of Ascendis PV group

Competencies Identified for success:

Works effectively, independently, and collaboratively
Strong organizational skills, detail oriented and adapts in a dynamic, fast paced environment
Demonstrates ownership, initiative, and accountability
Ability to interact as an effective team player encouraging collaboration in a multifunctional and multidisciplinary team setting
Excellent communication skills, both written and verbal, with credibility and confidence
Sound strategic evaluation, analysis, and decision-making skills as demonstrated in effective strategy formulation, tactics, and action plans to achieve results
Displays a high level of commitment

The estimated salary range for this position is $220-245K/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.

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.

Requirements

Health Care Professional degree required (e.g., B. Pharm, PharmD, RN etc.)
Candidates with advanced scientific degrees and extensive drug safety experience is highly desired
Minimum of 10 years recent experience in Pharmacovigilance
Minimum of 5 years of people management experience (preferred)
Working knowledge of validated Drug Safety Databases (Argus preferred)
Experience with MedDRA coding and global safety reporting regulatory requirements
Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations
Ability to travel up to 20% of the time domestically and internationally

Benefits

401(k) plan with company match
Medical, dental, and vision plans
Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
Company-provided short and long-term disability benefits
Unique offerings of Pet Insurance and Legal Insurance
Employee Assistance Program
Employee Discounts
Professional Development
Health Saving Account (HSA)
Flexible Spending Accounts
Various incentive compensation plans
Accident, Critical Illness, and Hospital Indemnity Insurance
Mental Health resources
Paid leave benefits for new parents

Ascendis Pharma

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Director, Head, ICSR Management Team - Job ID: 1598