Head, Global Medical Safety Science

Ascendis Pharma
 Palo Alto, CA

Description

Head of Global Medical Safety Science reports to VP, Head of Pharmacovigilance and Global Drug Safety. Located within Global Safety department, the Head of Global Medical Safety Sciences is a leadership role and has global responsibility for safety sciences support of all development and marketed products in Ascendis portfolio to meet GVP requirements. This role will lead the global medical safety science team in the analysis of safety data, identifying, detecting and investigating safety signals, evaluating and proactively managing risk, and providing medical safety review for Ascendis’ investigational compounds and market products. Line management responsibility for a team in the global Pharmacovigilance department which covers the drug safety surveillance, signal detection, safety evaluation, and safety management.

Key Responsibilities:

  • Management of a Team of Medical Safety Scientists, Medical Safety Directors and other safety experts: Forms, aligns, empowers, and develops a global team of specialized medical safety science individuals around a clear set of standards and strategic objectives
  • Provide strategic oversight of the Medical Review of Individual Case Safety Reports (ICSR)
  • Support to Drug Safety Committees (DSCs): Provides permanent members, contributors and experts for the Drug Safety Committees (DSCs)
  • Integrated Safety Surveillance and Signal Detection: Provides leadership to the approach and methods for safety signal detection and analysis, and executes this activity
  • Aggregate Reporting: Performs the required data retrieval and analysis and oversees the preparation of DSURs, PSURs, PBRERs and PADERs
  • Signal Detection and Analysis, Data Mining and Medical Coding: Builds the tools and capabilities necessary to detect and evaluate signals and safety issues under the auspices of the quality system required in GVP to ensure patient safety, provide justification for the labels of Ascendis products, prepare aggregate reports, and provide responses to Health Authority questions
  • Lead and /or contribute to the creation and maintenance of Reference Safety Information
  • Quality Management: Ensures all Global Medical Safety Sciences work is done within the framework of the Pharmacovigilance System and the quality system for pharmacovigilance required by regulations.
  • This entails tracking, document storage in validated IT systems and a continuous audit trail of methods, analysis, conclusion activities and decision-making
  • Regulatory Agency Requests: Responsible for timely and concise safety analysis and safety data responses to Regulatory Agency requests relating to patient safety
  • Inspections: Ensures appropriate readiness for audits and inspections and accountable for regulatory agency inspection findings and internal audit findings relating to areas of responsibility are addressed and resultant Corrective Action Plans (CAPA plans) are implemented efficiently and effectively in the function
  • Works closely with Head of PV operations and QPPV Europe, participates in planning, designing and support of all US pharmacovigilance operation activities related to enable global product launch activities.
  • Provides expert level consultation on safety risk management, signal detection, and
  • Authors or contributes to Safety sections of BLA/MAAs and other regulatory submissions (e.g., integrated summary of safety, and/or summary of clinical safety, RMP, etc.)
  • Ensures compliance with US and international pharmacovigilance regulations.
  • Participates/leads in Vendor selection and Vendor management.

epidemiological issues to a variety of stakeholders across Ascendis programs.

Requirements

  • MD or PhD (or international equivalent) plus accredited postgraduate training
  • Ten (10) years pharmaceutical / biotechnology industry experience, of which at least five (5) should be in a Medical Safety Sciences related role, with oversight of safety sciences fields and specific experience in epidemiology, quantitative methods, signal detection, data mining and benefit-risk
  • Minimum five (5) years of previous line/matrix management experience and a record of accomplishments in managing and developing people preferred
  • Experience and success in addressing and managing complex safety issues using scientific approaches in the pre-approval and post-approval environments
  • Sound understanding of scientific disciplines in the area of safety and PV with good ability to communicate on medical and scientific concepts
  • Working knowledge of Safety Databases (ARGUS, or other safety database applications) and Electronic Data Capture (EDC) systems
  • Demonstrated knowledge and understanding of drug development
  • Scientific expert who understands the complexities of pharmaceutical medicine and the delivery of healthcare
  • Strategic proficiency in crafting approach to relevant FDA, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments (including ICHGCP/CIOMS best practices).
  • Proficiency with safety databases and safety coding dictionaries (e.g., MedDRA, WHODRUG).
  • Detail-oriented, with good organizational, prioritization, communication, and time management proficiencies.
  • New hires based in the US will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law
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