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2017-43606

2017-43606

Title 
Senior Director of Global Patient Safety
Job Locations 
-
US-PA-Blue Bell
US-Remote
Canada-Remote
US-NC-Raleigh
US-VA-Charlottesville
Germany
United Kingdom-Swansea
EU-Remote
Posted Date 
10/26/2017

More information about this job

Overview

We are currently seeking an experienced Pharmacovigilance leader. Activities include overseeing the following, as applicable to drugs, biologics and devices throughout the life-cycle of a product, with a particular emphasis on post-marketed products.

  • Risk Management Plans (RMPs)
  • risk minimization activities
  • Risk Evaluation and Mitigation Strategies (REMS)
  • design and analysis of safety studies
  • epidemiology reports safety/risk management aspects of observational studies
  • label changes
  • signal detection and investigations
  • benefit-risk assessments

Responsibilities

  • Leads a team of Safety & Risk Management experts
    • Manages performance and supports growth of assigned direct reports
  • Builds and aligns a technical team to perform critical operating tasks meeting or exceeding client and PRA expectations.
  • Supports the strategic and operational functions of the business unit Safety & Risk Management to meet its goals and project objectives.
  • Provides leadership and consultancy to clients and project teams delivering services in the areas of cumulative safety reports, benefit-risk assessments, epidemiology, signal detection and investigations, design and analysis of safety studies, risk management plans and risk minimization activities, pharmacovigilance audits and inspection preparation including generation of a project plan in close cooperation with project team.
  • Initiates and leads the development and implementation of processes, systems and tools to broaden service offerings and/or improve efficiencies in PRA’s safety & risk management services.
  • Member of Steering/Executive Committees as part of relationship governance, attendance of related meetings and resolution of escalated issues.
  • Participates in developing new and existing business by attending sales presentations and interacting with clients.
  • Creates an environment that encourages learning, self-improvement, and career development for staff.
  • Develops, implements, and delivers training for employees providing safety and risk management services, including cross-functional training.
  • Contributes to the implementation of sales & marketing strategies (e.g. for new service offerings or specific target clients).
  • Participates and presents at conferences.
  • Takes a lead role in growing PRA’s safety & risk management services through client retention, acquisition of new clients, expansion of service offerings, attraction of safety experts, staff development and strategic alliances.

Qualifications

Qualifications:

  • Monitors projects within the business unit to assure PRA profitability, associated project goals and objectives of high quality deliverables are met.
  • Maintains familiarity with current industry practices and regulatory requirements that affect benefit/risk evaluations, NDAs/BLAs/MAAs, and changes to labeling and marketing authorizations.
  • Substantial experience in the pharmaceutical industry with significant experience in a leadership position in safety and risk management in industry-related clinical research.
    • Demonstrated experience in a line management role.
  • Proven history of successful involvement driving a strategic, global, cross-functional initiative.
  • History of successful in interactions with regulatory authorities, IRBs/Ethics Committees, medical community, knowledge of regulatory requirements for human drugs, biologics, and/or devices.
  • Proven history of leadership of business development initiatives.
  • Experience in preparing, implementing, and managing departmental operating plans.
  • Experience in process re- engineering.
  • An advanced degree (M.S. or Ph.D.) from an accredited institution in medicine, pharmacy or other life-sciences.
    • Postgraduate degree in epidemiology, statistics or public health or equivalent degree, preferred.
  • Excellent written and oral communication and presentation skills.
  • Reads, writes, and speaks English; fluent in host country language required.

LOCATION: This position can be located in the United States, Canada, Germany, the UK or another EU country. Options are available for a home-based or an office-based position in the locations noted.

 

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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