layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Director, ICSR Management Team - Job ID: 2018 at Ascendis Pharma | LAYIQ

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 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

Director, ICSR Management Team - Job ID: 2018

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