Director, ICSR Management Team - Job ID: 2018

About this role

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, 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, 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 assigned 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 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…