Prothena

Senior Director, Global Safety Operations

US-CA-South San Francisco
Job ID
2017-1176
Category
Research & Development

Overview

The Senior Director of Global Safety Operations will be the primary point of contact accountable for ensuring effective, high quality and efficient management of staff, processes and cases to comply with global regulatory timelines related to global adverse event case processing and expedited submissions.

Responsibilities

  • Expert in Pharmacovigilance and GCP/ICH compliance requirements and guidelines, as well as in applicable Prothena and/or partner SOPs
  • Management of workload and resources for global operations team to meet global regulatory timelines
  • Supervise operations personnel (direct reports, consultants and vendors) including mentoring, training, and creating an environment for individual growth through problem­ solving, decision-making and self-directed learning
  • Coordinate and chair regular team meetings
  • Provide strategic management and policy proposals for the operations team
  • Ensure consistency of work practices across teams both locally and globally
  • Accountable for identification, initiation, development and implementation of PV process improvements, tools, systems and procedures to enable excellence and consistency in operations in collaboration with other managers/supervisors
  • Provide expert safety/pharmacovigilance guidance to clinical trial project teams and/or external partners to develop procedures and logistics for clinical trials
  • Responsible for the oversight, management and communication for all future global business partner safety data exchange agreements and other contracts as applicable and ensure compliance with data exchange activity
  • Work with QA/Compliance to ensure compliance of Operations procedures and training
  • Develop and maintain SOPs, policies, procedures and standards for case processing
  • Ensure compliance-related investigations, and development and implementation of corrective actions for deviations from case processing procedures are performed accurately and on time
  • Interact with direct reports on safety issues arising from both Phase 1-3 development and future marketed products
  • Interact with global country operations- colleagues related to operational issues/data quality issues
  • Participate in regulatory inspections and audits to ensure the quality, integrity and compliance with pharmacovigilance and safety reporting requirements, including authoring of responses to findings relevant to functional area
  • Participate in budget planning and management
  • Work closely with the department head and other functional teams to maintain an effective and compliant system for monitoring the safety profile of compounds in development
  • Actively participates in the development and maintenance of risk management activities
  • Partners with other departments including Clinical Operations, Clinical Development, Regulatory Affairs, Legal to support clinical, medical and regulatory strategies, company goals as well as to communicate and address safety findings
  • Work with Medical Affairs on safety management for ISTs
  • Assist in the preparation of relevant sections of clinical study reports, annual reports, expedited safety reports and other regulatory filing documents
  • Establish and maintain an electronic global safety database for tracking, storing, and reporting serious adverse events of all Prothena development and future marketed products. This will include system and/or vendor selection, implementation and validation, as needed
  • Other duties as assigned

Qualifications

Education and/or Experience:

  • Advanced degree in life sciences, nursing, pharmacy or medicine; PhD, PharmD, RN.
  • At least 8 years’ experience in global Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments. A minimum of 5 years of functional management experience overseeing PV staff
  • A thorough understanding of the global PV regulatory environment with working knowledge of EU and US regulations, ICH guidelines, and GCP, a working understanding of drug safety databases, effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective
  • Thorough understanding of the clinical drug development process
  • The position demands excellent interpersonal skills, decision-making, and ability to adapt to a dynamic and complex regulatory and business environment
  • This position also requires a commitment to process improvements, excellent organizational skills, excellent written and verbal communication skills, and a strong commitment to best practices, and the ability to work effectively as both a functional area manager as well as cross-functional project team member
  • Computer literacy is essential
  • Ability to travel up to approximately 20% domestically and/or internationally

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

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