Prothena

Senior Medical Director, Global Safety Science

US-CA-South San Francisco
Job ID
2017-1167
Category
Research & Development

Overview

The Senior Medical Director of Global Safety Science is responsible for strategic leadership and medical oversight of Prothena activities in collaboration with Prothena Global Safety and Pharmacovigilance colleagues, applicable cross-functional specialists and the EU Qualified Person for PV (EU QPPV), with special focus on identification, evaluation and management of safety risks throughout product lifecycle.

Responsibilities

Direction and oversight of the Safety Science group;

  • Ensuring effective leadership of cross-functional safety management teams
  • Ensuring high quality Safety Science support for Development Sciences
  • Ensuring quality authorship of required aggregate safety reports and core safety information for products
  • Providing medical expertise for Prothena Global Safety and Pharmacovigilance
  • Ensuring quality authorship of Risk Management Plans (RMP)
  • Authoring and/or providing input on responses to regulatory authority safety-specific inquiries
  • Authoring and/or providing input on Pharmacovigilance policies and standard operating procedures
  • Coordinating Prothena Global Safety and PV contributions to marketing authorization applications
  • Providing senior level PV representation on product-specific and/or clinical study teams and executive committees
  • Mentoring and coaching Safety Science staff

 

Qualifications

Education and/or Experience:

  • Degree in Medicine, Pharmacy or Nursing
  • Pharmaceutical industry background and proven competence in PV required
  • Minimum of 5 years of Pharmacovigilance experience; with previous signal detection/safety surveillance and international experience preferred
  • Minimum 1 year medical/clinical experience post-graduate training
  • Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data to both healthcare professionals (HCPs) and non-HCPs
  • Thorough understanding of the drug development process and context applicable to safety surveillance activities
  • Strong working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; Volume 10 clinical trials directive; Guideline on Good Pharmacovigilance
  • Practices (GVP) and ICH Guidelines)
  • Knowledge of MedDRA terminology and its application
  • Experience in the preparation and authoring of pre- and post-aggregate safety reports, RMPs, and Reference Safety Information
  • Thorough understanding of the drug development process and context applicable to safety surveillance activities
  • Proficiency in Microsoft Office and experience with safety databases; Argus experience required

Competencies and Attributes:

  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and core values – courageousness, creativity, selflessness and humor
  • Excellent verbal and written communication skills as well as presentation and team-interaction skills are required
  • Strong time management, prioritization, organizational and multitasking skills are required
  • Excellent interpersonal, team management and leadership skills

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